Orthopedic Implants in Michigan

Materialise N.V. is a global 3D printing and personalized healthcare technology company with 35+ years of experience in additive manufacturing. The company operates two primary business divisions: Industrial and Healthcare. The Industrial division provides 3D printing services for prototyping and serial manufacturing, alongside software solutions for managing in-house 3D printing operations across manufacturing workflows. The Healthcare division offers personalized medical solutions including 3D surgical planning software, biomechanical analysis tools, custom-made implants (including PEEK and other materials for craniomaxillofacial, orthopedic, and other applications), and clinical decision-support systems for healthcare professionals, medical device manufacturers, and academic institutions. Materialise develops software platforms for 3D modeling, image segmentation, surgical simulation, and pre-operative planning, with clinical applications spanning craniomaxillofacial surgery, orthopedics, and general surgical planning. The company serves hospitals, surgery centers, device manufacturers, and industrial customers globally. Products emphasize mass personalization, sustainability in manufacturing, and clinically validated outcomes. Materialise maintains ISO 13485 and quality management certifications relevant to medical device manufacturing and provides software and hardware solutions for personalized healthcare engineering.

Citagenix, operating as the US division of HANSAmed Limited since 1997, is a global supplier of regenerative biomaterials for dental, periodontal, implant, and orthopedic applications. The company manufactures and distributes a comprehensive portfolio of allograft-based bone grafts, barrier membranes, matrices, and biologics for guided bone regeneration (GBR), guided tissue regeneration (GTR), ridge preservation, and socket grafting. Core product lines include Raptos® demineralized bone matrix (DBM) putties and particulates (100% human allograft), ProtFactor™ lyophilized allograft-derived protein supplements enriched with naturally occurring growth factors, CevOss™ deproteinized bovine bone, Neomem® resorbable collagen membranes (derived from porcine peritoneum and amnion-chorion), and specialized wound dressings (NeoPlug™, NeoCote™, NeoTape™). The company also supplies surgical essentials including bone and membrane fixation devices, specialized instruments, and regenerative accessories. Products are marketed to dental surgeons, periodontists, implant dentists, and oral surgeons primarily through an extensive North American distributor network including major dental supply chains (BencoDental, Burkhart, Darby, Frontier). Citagenix emphasizes clinical evidence, handling characteristics, and osteoinductive/osteogenic potential in regenerative applications. The company maintains direct sales support and operates an AI-assisted product information chat system.

Summit Labs LLC is a Michigan-based custom orthotic manufacturer specializing in direct-milled accommodative and functional orthotics for healthcare professionals. The company produces true total contact orthotics using advanced materials with denser foam and smaller cell structures designed to resist compression and ensure long-term durability. All orthotics are manufactured in-house with rapid turnaround times of 3–5 days. Summit Labs serves a diverse market including orthopedics and prosthetics (O&P) practitioners, podiatrists, DME providers, chiropractors, rehabilitation centers, certified pedorthists, cobblers, athletic trainers, comfort shoe retailers, wound care centers, and orthopedic surgeons. The company offers versatile custom fitting capabilities for standard footwear (work boots, running shoes, hiking boots, athletic cleats, basketball shoes, ski boots, ice skates) as well as specialized devices including AFOs (ankle-foot orthotics). Products are manufactured from quality materials selected for durability and patient comfort. The company operates with a procurement-focused service model supporting professional healthcare and mobility markets.

BioPro, Inc. is a privately held orthopedic medical device manufacturer based in Port Huron, Michigan, established in 1987. The company designs, manufactures, and distributes a comprehensive portfolio of orthopedic implants and surgical devices targeting foot, ankle, hand, wrist, and total joint applications. BioPro's product lines combine established designs with innovative technologies to address common orthopedic conditions including CMC joint arthritis, hallux rigidus, flatfoot deformities, and soft tissue reattachment needs. With approximately 26 employees and annual revenue of $6.8 million, BioPro serves surgeons and patients seeking solutions for pain relief and functional restoration. The company also provides contract manufacturing services and maintains a network of surgical representatives for clinical support and education.

hg Medical Group is a contract manufacturer of complex orthopedic implants and instruments for spinal and extremities applications. The company operates state-of-the-art manufacturing facilities in Holland, Michigan (USA); Huntington, West Virginia (USA); Raisting, Germany; and Spaichingen, Germany, with over 350 employees across four locations. hg Medical specializes in precision CNC machining using fully automated HERMLE 5-axis mills, Tornos and Traub Swiss turning equipment, and Haas machining centers, enabling production of intricate implants from stainless steel and titanium. Product portfolio includes orthopedic plates (compression, locking, reconstruction, buttress, bridging, and specialty designs for clavicle, distal radius, proximal humerus); orthopedic screws (lag, cortical, cannulated, and reduction screws); intramedullary nails with extreme diameter-to-length ratios and cross-hole precision; surgical drill bits and reamers; and surgical instruments (drill guides, depth gauges, targeting jigs, cutting guides, polyaxial locking screws, rods, and adjustable cages for spinal fusion). The company operates hg labs, an in-house R&D engine providing rapid prototyping, design feedback, and accelerated product development cycles. ISO 13485:2016 and FDA 21 CFR Part 820 certified with documented FDA audit success. Serves OEM customers ranging from market leaders to early-stage device companies across orthopedic trauma, spine, and extremities markets.

Royal Oak Medical Devices is a precision medical device manufacturer specializing in orthopedic implants and components. Operating from an 18,000 sq ft state-of-the-art facility established in 2013 in Rochester Hills, Michigan, the company designs and manufactures FDA 510(k)-approved devices including pedicle screws, lumbar cages, and custom orthopedic components. The company works with advanced materials including titanium, cobalt chrome, stainless steel, PEEK, and thermoplastics. Manufacturing capabilities include multi-axis CNC turning and milling, wire EDM, ultrasonic cleaning with pharma-grade water, laser marking, and proprietary surface finishing techniques. The facility supports full capabilities from prototype development through full-scale production with in-house design engineering and consulting services. Quality systems include rigorous QC vision systems and lights-out manufacturing automation. The company is ISO 13485:2016 certified with design, 21 CFR 820 compliant, and FDA registered. Royal Oak Medical serves orthopedic device manufacturers and healthcare systems requiring custom implants and precision-machined components.

Shoulder Innovations, Inc manufactures and markets the InSet® Total Shoulder System, a comprehensive line of shoulder arthroplasty implants designed to improve glenoid survivorship and patient outcomes. The company specializes in total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) solutions. The InSet® Glenoid component addresses the rocking horse effect through a proprietary design intended to extend implant longevity. The InSet® Reverse employs a lateralized-lateralized design architecture to optimize range of motion and reduce post-operative complications. The company offers streamlined, economically efficient tray systems designed for both hospital and ambulatory surgical center (ASC) settings, emphasizing cost efficiency and surgical workflow optimization. Shoulder Innovations focuses on evidence-based clinical outcomes, publishing results and clinical data to support surgeon adoption. The company operates with a dedicated leadership team committed to improving patient and surgeon outcomes in shoulder reconstruction. Products are positioned for orthopedic surgeons and hospital procurement teams seeking shoulder implant solutions.

Able Medical Devices is a precision-machined surgical implant and instrument manufacturer serving the orthopedic and thoracic medical device sectors. The company specializes in custom product development, design optimization, and scalable manufacturing partnerships with medical device OEMs. Their core capabilities include mechanical design, precision machining, product engineering, and supply chain management. Able manufactures implants such as the Valkyrie® RIB Thoracic Fixation System and provides engineering services across product development, technology transfer, and advanced manufacturing. The company maintains expertise in regulatory compliance (FDA, ISO standards) and quality assurance, with a team of engineers and operations professionals with 20+ years of experience in medical device R&D and manufacturing at organizations including RTI Surgical and Pioneer Surgical. Able operates as a contract manufacturer and development partner, focusing on speed to market, cost optimization, and adherence to medical device regulatory requirements. The company is headquartered in Michigan and serves customers seeking reliable orthopedic and thoracic implant manufacturing and product development services.

Befitting You is a family-owned medical supply and orthotics/prosthetics company with multiple locations across Michigan (Commerce Township, Farmington Hills, Warren, West Bloomfield, Clarkston, Novi, and Detroit). The company specializes in custom orthotics and prosthetics, orthopedic bracing, and durable medical equipment. Product lines include foot and ankle braces, knee orthoses (hinged and ROM models), wrist and hand supports, shoulder braces, hip supports, and spinal braces. They also offer 3D-printed casting solutions through ActivArmor technology. Beyond orthopedic devices, Befitting You serves women's cancer care and maternity care markets. The company operates a retail and fitting service model, providing personalized care and support for patients requiring mobility aids, post-injury rehabilitation devices, and adaptive equipment. Their emphasis on custom fitting and family-oriented service positions them as a regional distributor and fitter of orthopedic and durable medical supplies. No specific regulatory certifications (FDA, ISO, 510(k)) are mentioned on the site.

Mount Mfg is a contract manufacturer of medical devices founded in 2015, specializing in orthopedic implants and instruments. Operating from a state-of-the-art 10,000 sq ft facility in Marquette, Michigan, the company serves the Spine, Extremity, Orthopedic, Trauma, and Dental industries. Core competencies include CNC Swiss turning and milling (up to Ø38mm with 5-axis capability), secondary finishing (bead blasting, tumbling, buffing, polishing), laser marking for UDI compliance, and cleaning & passivation services. Quality infrastructure incorporates Industry 4.0 principles with real-time production monitoring, rigorous GD&T standards training, advanced inspection technology, and full regulatory compliance support for global markets. The company is committed to precision manufacturing and maintaining effective quality systems to meet evolving regulatory requirements.

GraMedica is a medical device manufacturer specializing in innovative foot and ankle surgical solutions. The company's flagship product is HyProCure, a minimally invasive sinus tarsi implant designed to realign the foot and correct biomechanical dysfunction. HyProCure is performed in less than 30 minutes with immediate weight-bearing capability and full activity resumption within two weeks. The device has demonstrated a 99% implant success rate in an 8-year peer-reviewed study published in Orthopaedic Surgery (2025), with over 100,000 implants placed globally since 2004. HyProCure maintains a complaint rate of 0.1% and removal rate of 5.2%, substantially lower than competing foot implants. GraMedica also offers HyProCure II (second-generation implant), Osteo-WEDGE (open wedge bone locking system for osteotomy), and Opti-Toe (lesser toe reconstruction device). The company supports surgeons with clinical training, patient education resources, and physician endorsement programs. Products are backed by 100+ clinical studies, including 25 peer-reviewed publications. GraMedica actively recruits medical device distributors and maintains a global presence across multiple countries and languages.

Xyresic LLC is an ISO 13485-2016 certified and FDA-registered additive manufacturing (3D metal printing) contract manufacturer specializing in medical implant production. Based in Jackson, Michigan, the company focuses on rapid prototyping and manufacturing of custom metal implants for the medical device industry. Xyresic leverages advanced additive manufacturing technology to reduce lead times by up to 16 weeks compared to traditional subtractive manufacturing methods and enables low-volume production without forced minimum purchase quantities, thereby reducing inventory holding costs for customers. The company serves medical device manufacturers requiring complex metal implant geometries, custom components, and flexible production schedules. Their quality system is certified to ISO 13485 standards, demonstrating commitment to medical device manufacturing requirements and regulatory compliance. Core capabilities include metal additive manufacturing design consultation, rapid tooling, and on-demand production runs. Xyresic markets itself as an alternative to traditional contract manufacturers for customers seeking shorter lead times, lower minimum order quantities, and engineering expertise in implant design optimization.

hg medical GmbH is a manufacturer of orthopedic implants for bone surgery, operating manufacturing facilities in Raisting, Germany and Huntington, West Virginia, USA. The company specializes in precision machining of approved raw materials including titanium, stainless steel, and PEEK for orthopedic applications. hg medical serves both established market leaders and dynamic startups in the orthopedic sector, with a commitment to quality management and regulatory compliance. The company employs advanced machining centers and maintains comprehensive traceability systems for all manufactured implants. As of 2022, hg medical had produced significant volumes of orthopedic implants and operated multiple state-of-the-art processing facilities. The organization emphasizes sustainability, quality assurance, and regulatory adherence, with dedicated focus on materials processing technologies and manufacturing excellence. Products are marketed to the orthopedic surgery community globally.