Orthopedic Implants in Indiana

27 vendors serving Indiana

Find orthopedic implants vendors in Indiana. MedIndexer lists vendors headquartered in Indiana alongside nationwide vendors that serve Indiana. Compare profiles, review service areas, and contact vendors directly — no middleman, no fees for buyers.

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MEDARTIS AG

Medartis Holding AG is a Swiss-based orthopaedic medical device manufacturer specializing in implants and surgical instruments for head and extremity surgery. The company operates globally with subsidiaries in Germany, UK, Switzerland, Spain, France, Mexico, USA, Poland, Austria, Japan, Australia, and Brazil. The product portfolio is organized into four primary divisions: CMF (craniomaxillofacial) solutions for midface, mandible, and orthognathic procedures; Upper Extremities (Aptus line) covering hand, wrist, forearm, elbow, and shoulder indications; Lower Extremities including foot and ankle systems; and CMX, a customization service offering bespoke implants, saws, and drill guides for complex cases. The Aptus product line includes systems such as the Distal Radius and Distal Ulna System 2.5, Hand 1.2–2.3, and Hallux System 2.8. Medartis reported 2025 total sales of CHF 269.3 million with 15.7% organic growth and a core EBITDA margin exceeding 18%, indicating significant market presence. The company is listed on the SIX Swiss Exchange (ticker: MED) and serves hospitals, surgical centers, and orthopaedic practices globally. Regulatory compliance and clinical research partnerships support product credibility in the orthopaedic implant market.

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BoxSPINE, LLC

BoxSPINE is a medical device company specializing in ready-to-use, pre-sterilized spinal implants and surgical instruments designed for ambulatory surgery centers (ASCs) and spine care providers. The company develops proprietary, single-use disposable surgical kits targeting the posterior lumbar spine market. BoxSPINE's product strategy emphasizes infection reduction, improved operative room efficiency, and cost containment through simplified inventory management. The company partners with leading technology providers to deliver advanced surgical solutions; notably, BoxSPINE has entered a strategic distribution agreement with PathKeeper Surgical to bring PathKeeper's radiation-free, sub-millimetric spinal navigation systems to key US ASC locations under the 'BoxSPINE 100' initiative. The company is led by experienced medical device executives with a combined track record in surgical device manufacturing, sales, and business development. BoxSPINE's target market includes ASCs seeking to reduce primary and secondary costs while maintaining high patient safety standards and minimizing infection and revision rates associated with current spinal implant systems.

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Jatex, Inc.

Jatex, Inc. is a contract manufacturer specializing in precision-machined components for the orthopedic, spinal, and extremity medical device industries. Founded over 25 years ago as a family-owned business, the company operates a 14,000+ sq. ft. facility in Nappanee, Indiana, producing implant and instrument components ranging from prototype quantities (1–10 units) to full production runs (100+). The company employs advanced CNC machining capabilities including 3-, 4-, and 5-axis milling, 6-axis Swiss lathes, and wire EDM, complemented by metal finishing services (polishing, roto finishing, laser marking). Additional services include heat treating, anodizing, electropolishing, PVD coatings, certified welding, and non-destructive testing (dye penetrant and X-ray). Jatex maintains ISO 13485:2016 certification and a validated quality management system approved by orthopedic industry experts, achieving preferred supplier status with major medical device manufacturers. The company emphasizes precision, on-time delivery, comprehensive inspection protocols, and competitive pricing.

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SITES Medical, LLC

SITES Medical is an orthopedic implant technology company specializing in platform technology development, contract R&D, and contract manufacturing services for orthopedic original equipment manufacturers (OEMs). The company's core offering is OsteoSync Ti, a porous titanium ingrowth material designed for superior bone ingrowth, high initial stability, and substrate compatibility with cobalt-chromium and titanium. OsteoSync Ti has achieved over 250,000 devices implanted across multiple OEM partners' product lines. SITES Medical also offers complementary platform technologies including OsteoSync Flex, OsteoSync Rx, and OsteoSync PEEK to address varied orthopedic applications. The company provides end-to-end concept-to-launch R&D services, including regulatory filings and clinical support, leveraging an extensive network of experts. Manufacturing capabilities include state-of-the-art wire EDM equipment and full-service production to reduce costs while maintaining quality standards. Domain expertise spans orthopedic joints (hips, knees, extremities, trauma, sports), spine (interbody fusion devices, disc replacements, vertebral body replacements, pedicle screws, plates), dental (implants, reconstructive meshes), and adjacent markets (veterinary, craniomaxillofacial, cochlear). Founded in 2008, the company operates as an innovation partner to OEMs seeking competitive advantage through differentiated implant technologies. Key partnerships include Spineology (expandable interbody fusion), MicroPort (revision knee tibial cones), and Medtronic (nano surface technology integration for PEEK interbodies).

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OrthoPediatrics Corp

OrthoPediatrics Corp is a medical device manufacturer specializing exclusively in pediatric orthopedic products and solutions. Headquartered in Warsaw, Indiana, the company designs and manufactures implants, fixation devices, and surgical instrumentation specifically engineered for the unique anatomical and clinical needs of children and adolescents. Their product portfolio spans multiple pediatric orthopedic specialties including trauma management, deformity correction, external fixation systems, scoliosis treatment, sports medicine reconstruction (ACL and MPFL procedures), and post-operative care solutions. The company recently launched PediHip™ System for hip dysplasia treatment and management. OrthoPediatrics also operates KIDSenablingtech.com, an enabling technologies business division supporting the pediatric orthopedic field. The company emphasizes evidence-based, technology-driven approaches to pediatric orthopedic care, with products designed to improve surgical efficiency and patient outcomes. OrthoPediatrics serves pediatric orthopedic surgeons, surgical centers, and hospitals across multiple markets. The company provides clinical education and training to orthopedic surgeons and residents on innovative surgical techniques. Products are manufactured to meet high quality standards appropriate for pediatric applications, though specific regulatory certifications are not detailed in the available content.

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Complexus Medical

Complexus Medical is a contract manufacturer specializing in orthopedic and spine surgical instruments and implants. Founded in 1968 as a tool and die shop, the company has evolved into a precision manufacturer serving the medical device sector. Primary products include complex orthopedic instruments, surgical hand tools, metallic and non-metallic implantable components for knee replacement, and single-piece surgical instruments. The company operates from Mishawaka, Indiana, and offers in-house capabilities spanning design, precision machining, assembly, and finishing. Complexus is committed to regulatory compliance and adherence to international standards for medical device manufacturing. The company serves OEM medical device manufacturers seeking to outsource component and assembly production to reduce costs and accelerate time to market. Core competencies include precision metalworking, implant fabrication, and complex surgical instrument assembly. Regulatory compliance and quality control are central to operations, with programs designed to meet statutory requirements and international standards for orthopedic and spine devices.

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Maitland Engineering

Maitland Engineering is a precision contract medical device manufacturer specializing in orthopedic implants. Located in South Bend, Indiana, the company operates as a dedicated precision machine shop with a team of highly skilled engineers, machinists, finishers, and inspectors. They provide custom manufacturing services including CNC Swiss machining, laser etching, EDM grinding, and finishing operations on materials such as stainless steel, cobalt, and plastics. The company is ISO 13485:2016 certified and offers scalability from single-piece production to high-volume manufacturing (up to 1,000,000+ parts). Their capabilities include tight-tolerance machining, quality control, and process optimization tailored to medical device specifications and supply chain requirements.

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Paragon Medical

Paragon Medical is a medical device manufacturing and component supplier specializing in end-to-end product development and precision manufacturing for medical OEMs. The company designs and manufactures precision components, surgical instrumentation, orthopedic implants, drug delivery systems, and single-use disposable devices across multiple surgical specialties including orthopaedics, cardiovascular, surgical robotics, dental, endoscopy, laparoscopy, and gastroenterology. Paragon operates FDA-registered manufacturing facilities with ISO 8 Class 100,000 certified cleanrooms for medical-grade packaging and labeling. The company provides comprehensive services spanning concept development, design control, regulatory affairs and FDA submissions, verification and validation testing, manufacturing scale-up, and commercialization support. Manufacturing capabilities include precision machining, additive manufacturing, and assembly of components from surgical materials, specialty alloys, and plastics in volumes ranging from prototype quantities to multi-million unit production runs. Paragon serves medical device manufacturers requiring contract manufacturing, OEM partnerships, and integrated new product development support. The company emphasizes vertical supply chain integration and functions as an extension of client in-house development teams.

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BHH Mikromed

BHH Mikromed is a Polish orthopedic implant manufacturer specializing in trauma and orthopedic fixation systems. The company produces a comprehensive range of orthopedic implants including screws, plates, wires, nails, and pins for trauma and orthopedic surgery applications. Product lines include DHS/DCS systems, locking compression plate systems (Locking Compression Plates Systems), and proprietary systems such as System Integracja® and Seven in One. The company serves orthopedic surgeons, trauma centers, and hospitals across Europe and participates in major medical device trade shows including Medica and Omnia Health Live. BHH Mikromed operates as a B2B medical device supplier with regulatory presence in the European market. The website indicates the company maintains professional-grade manufacturing and service capabilities with focus on precision and technology in orthopedic implant production.

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Micropulse, Inc.

Micropulse, Inc. is an orthopedic manufacturing and supply company founded in 1988 and headquartered in Columbia City, Indiana. Since 2003, the company has focused exclusively on the orthopedic market, serving major, mid-tier, small, and start-up orthopedic device and implant companies. Micropulse manufactures precision orthopedic instruments, orthopedic implants, custom surgical cases and trays, and provides sterile packaging services. The company operates under a Quality Management System compliant with ISO 13485:2016 and 21 CFR Part 820, positioning it as a regulated medical device manufacturer. Core capabilities include CNC machining, assembly, sterilization, and custom packaging for complete product solutions delivered under single purchase orders. Micropulse differentiates through vertical integration—machining, assembly, sterilization, and packaging under one roof—enabling customers to source implants and instruments from a single supplier with streamlined supply chain management. The company emphasizes quality, regulatory compliance, continuous improvement, integrity, and responsive customer service. Micropulse serves as a contract manufacturer and supplier for orthopedic OEMs and device companies navigating evolving regulatory requirements, price compression, and market consolidation. The company is led by CEO and Founder Brian Emerick.

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Restoration Medical Polymers

Restoration Medical Polymers (RMP) is a specialized manufacturer of ultra-high molecular weight polyethylene (UHMWPE) and medical-grade polymers for the orthopedic implant industry. Founded in 2015 by Lou Matrisciano and Brian Emerick, RMP operates a 48,000+ square foot manufacturing facility in Columbia City, Indiana, serving orthopedic OEMs of all sizes. The company specializes in compression molding expertise, custom polymer development, and supply chain solutions for implantable polymers used in orthopedic devices. RMP provides full production capabilities including material sourcing, technical development, design consultation, and manufacturing capacity with a focus on lead time improvement, cost optimization, quality assurance, and new product development. The company positions itself as a dedicated partner to orthopedic device manufacturers seeking reliable supply, technical expertise, and direct access to compression molding capabilities for UHMWPE and related biocompatible polymers used in joint replacement, bearing surfaces, and other orthopedic applications.

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SHANDONG LIANGYUE MEDICAL DEVICE TECHNOLOGY CO.,LTD

Shandong Liangyi Medical Devices Co., Ltd. is a Chinese medical device manufacturer specializing in orthopedic surgical instruments, precision components, and robotics-enabled end-effectors. The company designs and manufactures high-precision surgical instruments for total hip arthroplasty (THA), total knee arthroplasty (TKA), minimally invasive surgery (MIS), and orthopedic surgical robotics. Product lines include knee joint instruments, hip joint instruments, orthopedic saw blades, trauma and sports medicine tools, laparoscopic surgical robots, and specialized retractors such as the DAA (Direct Anterior Approach) Retractor System and THA Retractor System. Liangyi holds 4 invention patents and 20 utility model patents covering orthopedic surgical instruments. The company offers customized end-to-end services from clinical needs assessment through mass production, with modular architecture supporting rapid design iteration. Manufacturing capabilities include CNC machining and precision finishing of medical-grade stainless steel components. The company serves global orthopedic surgical markets and medical robotics manufacturers seeking precision actuators and end-effectors. Technical support and after-sales service are available 24/7.

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Sayan Tibbi Aletler Paz. San. ve Tic. Ltd. Sti.

Sayan Tibbi Aletler is a Turkish manufacturer of orthopedic implants and surgical instruments, founded in November 2005. The company specializes in the design and production of orthopedic implant systems across multiple surgical disciplines, including trauma fixation, hip arthroplasty (femoral and acetabular components), knee implants, spinal fixation devices, cable systems, and cement removal instruments. The company also manufactures general surgical and minimally invasive orthopedic surgical tools. Sayan positions itself on quality, customer satisfaction, and innovative product development. The company serves orthopedic surgeons and surgical centers with implant solutions for joint reconstruction, trauma surgery, and spine procedures. While specific regulatory certifications are not detailed in available content, the company operates from Turkey and maintains a web presence indicating international market engagement.

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ContainMed, Inc

ContainMed is a contract manufacturer of precision medical devices and instruments based in Indianapolis, Indiana. The company specializes in precision-machined implants and surgical instruments, custom graphic cases, and modular tray systems for surgical and orthopedic applications. Their product portfolio includes Graphic Cases for instrument organization and transport, Screw & Implant Caddies for secure storage and delivery of orthopedic hardware, and VersaPod, a proprietary modular tray system with FDA 510(k) clearance designed for flexible surgical instrument and implant delivery across various medical device platforms. ContainMed operates as a full-service contract manufacturer, offering capabilities from design and precision machining to custom packaging solutions. The company serves medical device manufacturers and surgical specialties of all sizes, providing both private-label manufacturing services and branded product lines. Their modular tray system is marketed as a robust, market-leading solution for diverse delivery and containment requirements in orthopedic and general surgical settings.

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BioPoly, LLC

BioPoly, LLC is an orthopedic medical device manufacturer based in Fort Wayne, Indiana, specializing in advanced synthetic cartilage implants for early-stage joint repair. The company develops proprietary biomaterial solutions combining hyaluronic acid (HA) and ultrahigh molecular weight polyethylene (UHMWPE) to create self-lubricated, durable cartilage replacements that mimic natural joint function. BioPoly's product portfolio includes implants for the great toe, lesser toe, radial head (elbow), and knee applications, designed to address cartilage defects and enable faster recovery compared to traditional joint replacement approaches. The implants serve as a minimally invasive intermediate solution between conservative biological treatments (microfracture, mACI) and total joint replacement. Products are manufactured using patented material science and are positioned for surgeons, distributors, and orthopedic specialists. The company maintains an active clinical development pipeline and is currently enrolling patients for investigational knee implant studies. BioPoly emphasizes patient outcomes, pain-free mobility restoration, and preservation of natural joint anatomy and biomechanics.

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Nanovis, LLC

Nanovis is a medical technology company specializing in nanotechnology-based surface technologies for orthopedic, spinal, and dental implants. Founded in 2006 and headquartered in Columbia City, Indiana, the company develops innovative nano-structured surfaces designed to enhance bone integration, reduce infections, and improve patient outcomes. The company's core technology, nanoVIS Ti™ Surface Technology, features controlled nanotube arrays that promote superior mineralization and osseointegration. Key product lines include Nano FortiFix® Pedicle Screws and Nano FortiCore® Interbodies for spinal fusion procedures. Nanovis has achieved significant regulatory milestones, including FDA clearance for the industry's first nanotechnology-designated pedicle screws and PEEK interbodies with porous titanium endplates. The company maintains strategic partnerships with major OEM partners, including an exclusive interbody technology agreement with Medtronic established in 2024. With a robust intellectual property portfolio and clinical validation through NIH-funded research, Nanovis is advancing the field of implant integration technology.

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DOT America, Inc.

DOT America, Inc. is a medical device coating and surface treatment specialist serving the orthopedic and dental implant industries. Based in Columbia City, Indiana, the company provides comprehensive surface preparation and coating services for medical implants and surgical instruments. Core offerings include PVD (physical vapor deposition) coatings for wear resistance; titanium plasma spray (TPS) coatings to promote osseointegration and bone growth; hydroxyapatite (HA)-sprayed coatings for rapid bone tissue formation; bone on-growth surface treatments to address implant loosening; Type II anodizing (DOTIZE®) for abrasion resistance and fatigue strength; and Type III color anodizing for multi-component implant systems requiring color differentiation for ease of use. The company also provides surface preparation services including polishing, micro-blasting, passivation, electro-polishing, and laser marking/engraving for FDA Unique Device Identification compliance. DOT America holds FDA facility registration #3011461101 and maintains ISO 13485:2016 certification through Intertek. The company operates as the US subsidiary of DOT GmbH (Rostock, Germany) and commenced operations in 2015 with an investment of approximately $4.5 million in Indiana. Products serve orthopedic, dental, and general medical device manufacturers seeking outsourced coating and surface modification capabilities. The company functions as both a contract manufacturer and strategic partner, offering integrated solutions for device performance enhancement and supply-chain consolidation.

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Qualitex NE LLC

Qualitex NE LLC is a precision contract manufacturing specialist serving the medical device, automotive, appliance, and agricultural sectors. The company operates two primary business units: Qualitex Medical and Qualitex Gage. Qualitex Medical is an ISO 9001, ISO 13485, and FDA-registered medical device manufacturer offering rapid prototyping, production machining, and full assembly capabilities for orthopedic implants, surgical instruments, and custom medical components. The company has manufactured over 35,000 external fixation rings for foot and ankle surgeries and 6,800+ surgical instruments for OEM partners ranging from Fortune 500 companies to startups. Qualitex Gage provides custom-designed gage and check fixtures for dimensional verification and quality control across industries. The company maintains an ISO 17025-accredited metrology laboratory equipped with multiple CMMs and optical comparators, supporting inspection processes and dimensional analysis. Core capabilities include CNC machining, wire EDM, CMM programming, production machining, and SPC systems implementation. Quality certifications include ISO 9001 and ISO 13485 for medical manufacturing, with demonstrated expertise in geometric dimensioning and tolerancing, dimensional layout services, and automated gage systems with PLC integration.

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SURESTEP, LLC

Surestep, LLC is a pediatric orthotic manufacturer specializing in custom-made braces and orthotic devices for children from infancy through development. The company designs and fabricates ankle-foot orthoses (AFOs), supra-malleolar orthoses (SMOs), cranial remolding helmets, and related lower-extremity support devices. Their product portfolio includes conventional thermoplastic devices and advanced 3D-printed solutions, with recent product innovations including SMO3D (a lightweight, flexible 3D-printed SMO) and Sprout3D (a cranial remolding helmet with demonstrated clinical superiority in head-shape correction). Surestep emphasizes rapid manufacturing turnaround—AFOs in 10–14 business days, SMOs in 4–8 days depending on customization method, and Sprout3D in 7–10 days—enabling quick delivery to pediatric physical therapists, orthopedists, and rehabilitation centers. The company markets its devices for children with balance disorders, gait dysfunction, hypotonia, plagiocephaly, and other developmental orthopedic needs. All devices are custom-engineered for comfort and growth accommodation. Surestep maintains a clinical focus, citing peer-reviewed research (Hanger Institute study) demonstrating superior outcomes with 3D-printed cranial devices. The company serves pediatric rehabilitation, orthopedic, and developmental medicine markets across the US.

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TriPoint Surgical

TriPoint Surgical is an ISO 13485-certified and FDA-registered contract manufacturer specializing in high-precision surgical instruments for orthopedic, dental, and neurosurgical procedures. Based in Columbia City, Indiana, the company manufactures custom surgical cutting tools including bone drills, broaches, rasps, reamers, and dental instruments. TriPoint's core competency is in-house CNC tool grinding, Swiss lathe turning, CNC milling, profiling, and customized assembly. The company grinds 100% of surgical tool cutting edges in-house rather than outsourcing, enabling rapid turnaround and design optimization. Services include custom coatings, flute design, self-centering tips, and cannulated configurations. TriPoint partners with surgical instrument suppliers, hospitals, and surgery centers to develop solutions for cutting, drilling, and securing bone, with expertise in prototype development through full production.

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REVELATION MEDICAL DEVICES LLC

Revelation Medical Devices (RMD) is an ISO 13485:2016 certified contract manufacturer specializing in precision medical device design, prototyping, and production for the orthopedic and spinal markets. With over 45 years of manufacturing heritage (formerly Stamets Tool & Engineering), RMD operates a 14,000 sq ft facility in Auburn, Indiana—strategically located 45 minutes from Warsaw, the orthopedic capital. The company serves medical device OEMs, startups, and established innovators with full-cycle capabilities including 3/4/5-axis CNC milling, live-tool turning, laser/TIG welding, laser etching, passivation, polishing, poly manufacturing, and non-sterile packaging/labeling. FDA-registered (No. 1836116) and committed to quality, on-time delivery, and partnership-driven development.

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Mach Medical, LLC

Mach Medical is an orthopedic contract manufacturer (CMO) specializing in High Velocity Manufacturing and High Velocity Engineering Transfer processes. The company serves OEM partners by designing, engineering, and manufacturing orthopedic implants with flexible, low-setup production capabilities. Mach's manufacturing platform enables economical production runs as small as one unit with near-zero machine setup time between product runs, supported by automated inspection and documentation systems. The company offers two primary inventory-reduction models: (1) direct supply of orthopedic implants with 3-week lead times in any order quantity, reducing customer warehouse inventory by up to 70%, and (2) case-templated, surgery-specific manufacturing that reduces overall OEM inventory (warehouse plus field deployment) by up to 85%, from 12+ months to 2–3 months. High Velocity Engineering Transfer leverages Siemens and Microsoft platforms with automated CNC programming and QMS documentation to compress engineering-to-production timelines to 3 months or less, potentially shortening time-to-market by 1–2 years versus traditional approaches. Mach Medical serves orthopedic OEMs and healthcare systems seeking supply chain agility, capital efficiency, and accelerated product commercialization.

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Precision Medical Technologies

Precision Medical Technologies is a contract manufacturer specializing in orthopedic and minimally invasive surgery (MIS) device design and manufacturing. Operating three facilities across northern Indiana, the company provides end-to-end solutions from design for manufacturability through prototype development to high-volume production. Product lines span orthopedic implants and instrumentation for knee, hip, spine, shoulder, trauma and extremities, and MIS applications. The company maintains ISO 13485:2016 certification and emphasizes tight-tolerance specifications, materials expertise, supply chain integration, and sterile packaging capabilities. Primary markets are OEM medical device manufacturers requiring contract manufacturing partners. The company operates through two divisions: Implant Division (Warsaw, IN facility) and Instrument Division (dual facilities in Rome City and North Manchester, IN). Service capabilities include design consultation, prototype-to-production scaling, materials selection, and full manufacturing in-house to reduce time-to-market and costs. Known for rapid quote response (24-hour turnaround) and vertical integration to streamline production workflows for emerging and established orthopedic technologies.

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Nexxt Spine LLC

Nexxt Spine LLC is a medical device manufacturer based in Noblesville, Indiana, specializing in the design, development, and in-house production of spinal implants and instrumentation for treating spinal disorders. Founded in 2009, the company is recognized as a leader in additive manufacturing within the spinal implant sector. Nexxt Spine's product portfolio includes 3D printed titanium interbodies (Matrixx® family), deformity correction systems (Inertia®), cervical plating solutions (Struxxure®, Saxxony®), and fixation options including translaminar screw systems (Facet Fixx®) and PEEK interbodies (Honour®). The company manufactures all implants and a significant portion of instruments in-house, supporting its commitment to American-made medical devices. Nexxt Spine has completed over 10,000 surgeries using its technology and continues to expand its sales teams across the US to meet growing demand. With estimated annual revenue around $14.6 million, the company focuses on enhancing procedural efficiency and patient outcomes through advanced technologies and surgeon collaboration.

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Thrive Orthopedics

Thrive Orthopedics manufactures custom carbon-fiber ankle-foot orthoses (AFOs) and related orthopedic braces for patients with ankle, foot, and lower-leg conditions including plantar fasciitis, equinus deformity, Lisfranc injuries, and general ankle instability. The company specializes in hand-crafted carbon-fiber AFO fabrication, leveraging advanced materials science and skilled artisan manufacturing. Core product lines include the F-Series Carbon Fiber AFOs, The Equinus Brace™, ankle braces, and carbon-fiber foot plates. Products are distributed exclusively through medical professionals (podiatrists, orthopedists, physical therapists, and clinics), ensuring clinical oversight and proper fitting. Thrive Orthopedics offers an industry-leading 2-year warranty on all carbon-graphite AFOs, demonstrating confidence in product durability and quality. The company emphasizes evidence-based design and has received clinical endorsements from practitioners treating conditions such as plantar fasciitis and complex foot injuries. Manufacturing capabilities include in-house hand fabrication by skilled technicians. The business model centers on B2B distribution via licensed medical professionals rather than direct-to-consumer retail, supporting clinical decision-making and patient outcomes.

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Culver Tool & Engineering LLC dba SpiTrex CTE

SpiTrex Orthopedics is a contract manufacturing partner specializing in orthopedic implants and surgical instruments. Operating as a fully integrated global manufacturing platform with facilities in Plymouth, IN (SpiTrex CTE); Lancaster, PA (SpiTrex MDI); Carlsbad, CA (SpiTrex 3D); and Le Locle, Switzerland (SpiTrex SWI), the company offers end-to-end manufacturing solutions from prototype development through validated production and finishing. Core capabilities encompass both additive manufacturing (3D printing) and subtractive manufacturing technologies tailored to high-performance implant and instrument production. All facilities are ISO 13485–certified and FDA-registered, meeting regulatory requirements for medical device manufacturing. The company provides design support, process validation, quality assurance, and scalable manufacturing aligned with medical device commercialization timelines. SpiTrex Orthopedics serves orthopedic device manufacturers requiring precision contract manufacturing with demonstrated compliance and manufacturing agility.

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Genysys 22, LLC

Genysys 22 is a vertically integrated orthopedic instrument and implant manufacturer specializing in contract manufacturing and rapid prototyping. The company serves the orthopedic device sector (spine, extremity, trauma, large joint) with in-house capabilities spanning turning, milling, Swiss turning, bending, welding, wire EDM, polishing, laser marking, and final assembly. ISO 13485:2016 certified, Genysys 22 combines old-school craftsmanship with modern machining to deliver prototypes within days and scaled production runs with rigorous quality control. The company emphasizes fast turnaround, reduced delivery time, and customer-centric service, functioning as an extension of client engineering and manufacturing operations.

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