Orthopedics in Massachusetts

EDGe Surgical, Inc. manufactures the Electronic Depth Gauge (EDG), a precision surgical instrument designed to improve accuracy and safety in orthopedic plating procedures. The EDG is an electronic depth measurement device that determines correct screw length for plate-and-screw fixation, reducing the risk of implant waste, infection, and procedure complications. The company's core value proposition addresses documented clinical challenges: conventional depth gauges are difficult to sterilize, leading to contamination risk; they increase OR time through measurement errors and screw replacement; and they necessitate additional fluoroscopy exposure to staff and patients. The EDG is marketed as more accurate, universally compatible with all major orthopedic plating systems (DePuy Synthes, Smith & Nephew, Arthrex, Paragon 28, Zimmer Biomet Acumed, Skeletal Dynamics, Medartis, Stryker, Globus Medical, Trimed, Conventus, Flower), and designed to be cleanable and sterilizable. The company reports adoption in over 60 hospitals across the United States. EDGe Surgical positions its device as infection-control-focused and cost-effective, addressing both patient safety outcomes and procedural economics.

Hike Medical is a healthcare technology company specializing in precision foot care and musculoskeletal (MSK) pain prevention, primarily serving blue-collar workforces. The company's flagship product is Hike Custom Insoles—clinical-grade, 3D-printed orthotic insoles manufactured in the USA at their SoleForge facility in Illinois. Using AI-powered technology, Hike enables users to create precise 3D foot models via a simple mobile scan (no app required), eliminating traditional barriers to custom orthotic care such as clinic visits and extended wait times. The resulting insoles are produced within two weeks and shipped directly to users. Hike partners with employers, healthcare providers, and clinics to address the rising costs and productivity losses associated with lower-body MSK conditions, which account for approximately one-third of all muscle and joint pain claims. The company has established partnerships with major organizations including OSF HealthCare and Fortune 100 manufacturers, demonstrating clinical validation and scale across diverse workforce segments.

Momentum Health Inc. develops Momentum Spine, a radiation-free 3D digital spine monitoring platform that uses smartphone video capture to create clinical-grade 3D spine scans and AI-powered analytics. The platform enables remote monitoring of complex spine conditions—particularly pediatric scoliosis (AIS) and adult spinal deformity—without requiring in-person X-rays or imaging center visits. The system employs deep-learning models to predict Cobb Angle (mean absolute error ~5–6°, comparable to inter-observer radiologist variation), track spinal asymmetry, assess brace compliance, analyze dynamic gait and posture metrics, and monitor whole-body sagittal alignment. Patients perform 45-second smartphone scans at home; clinicians access a secure web dashboard for real-time remote monitoring, triage, and data-driven intervention planning. Momentum Spine integrates into clinical workflows and supports Remote Therapeutic Monitoring (RTM) billing models. The company holds FDA 510(k) clearance (K232023, product code LDK) for the US market and Canadian Medical Device Establishment License (MDEL) clearance. The platform is SOC 2 Type 2 certified, HIPAA and PIPEDA compliant, and maintains ISO 13485 quality certification. Target markets include spine centers, hospital networks, pediatric orthopedic clinics, and research institutions. The company is based in Montreal, Canada, and serves leading healthcare systems including UCSF, NYP Och Spine, Cedars-Sinai, and Children's Hospital Los Angeles.

Circinus Medical Technology (operating as Bolt Navigation) designs and manufactures the Bolt Navigation System, a handheld, surgeon-controlled surgical navigation device for spine surgery. The system employs gyroscope-on-chip technology to provide accurate real-time guidance for pedicle screw placement and other spinal instrumentation procedures. Unlike conventional navigation platforms requiring expensive capital equipment, extensive imaging, or technician support, Bolt integrates seamlessly into existing OR workflows with minimal setup and zero footprint. The device is implant-agnostic, reducing radiation exposure for surgeon and patient while eliminating the need for preoperative registration or external imaging. Bolt operates on a flexible subscription model rather than capital purchase, making it particularly accessible to ambulatory surgery centers (ASCs). The system is designed to enhance surgical accuracy, improve workflow efficiency, reduce operative time, and lower total cost of ownership. The company targets surgeons and surgical teams across hospital systems and ASCs seeking radiation-reduced, cost-effective navigation without major infrastructure investment.

Eventum Orthopaedics is a UK-based medical device company founded in 2020, headquartered in Yorkshire, England. The company specializes in orthopedic surgical technology focused on improving patient outcomes in total knee arthroplasty (TKA). Their flagship product, Quadsense, is an intraoperative measurement system that provides real-time data on patellofemoral joint loading during knee replacement surgery, enabling surgeons to optimize kneecap positioning and soft tissue tension—a critical factor in reducing postoperative patient dissatisfaction. Quadsense received FDA 510(k) clearance in September 2024 and is protected under UK Patent GB2596906 and European Patent EP4157156B1, with three additional patents pending including US process patents. The company is developing Datasense, a complementary data analysis platform integrating preoperative, intraoperative, and postoperative metrics to support surgical decision-making. Eventum has secured £1.4 million in funding from Mercia Ventures and angel investors, including support from prominent orthopedic surgeons. The team combines expertise in orthopedic surgery, product development, medical device sales, engineering, and data analytics. The company targets the global TKA market, which encompasses approximately 2 million procedures annually, projected to reach 3.5 million by 2030. Eventum's technology addresses a documented clinical need: approximately 20% of TKA patients report dissatisfaction postoperatively, with anterior knee pain affecting approximately 8% of patients. The company markets to orthopedic surgeons and surgical centers seeking to improve functional outcomes and reduce revision rates.

Ranfac Corp. is an ISO 13485:2016-certified Contract Development and Manufacturing Organization (CDMO), Original Equipment Manufacturer (OEM), and Contract Manufacturing Organization (CMO) specializing in custom Class I and Class II single-use hypodermic-based medical devices. Founded in 1888 and based in Avon, Massachusetts, Ranfac operates a vertically integrated 40,000 sq ft facility that manages all production stages in-house: metal machining (12 specialized processes including CNC, laser welding, electropolishing), polymer injection and insert molding (Class 8 cleanroom), cleaning and passivation, cleanroom assembly (Class 7 ISO), and EO sterilization via exclusive STERIS partnership. The company serves minimally invasive surgery access devices, biopsy and aspiration systems, orthobiologics delivery cannulas, interventional radiology components, hematology devices, and general surgery instruments. Ranfac supports low minimum order quantities and scales from prototype to 500K+ units annually. MDSAP, EU MDR, and FDA registered, enabling simultaneous access to seven export markets.

Kirwan Surgical Products LLC is a Massachusetts-based manufacturer of microsurgical instruments and electrosurgical devices serving ophthalmology, otolaryngology (ENT), plastic and reconstructive surgery, and orthopedic specialties. The company designs and manufactures bipolar and monopolar forceps, generators, pencils, suction coagulators, and ancillary surgical instruments. Product lines include the POLARIS™ reusable bipolar forceps (single-piece high-performance non-stick design), AURA™ non-stick bipolar forceps (35+ years of R&D), and Liberty™ disposable bipolar forceps. The company offers bipolar generators in 20-Watt, 40-Watt, and 70-Watt configurations, all lightweight and compact. Additional offerings include disposable and reusable bipolar pencils (14–27 gauge), monopolar forceps with serrated tips, microdissection needles and electrodes, battery cauteries (low and high temperature models), I/A handpieces (straight and curved styles, autoclavable), Side by Side probes for intranasal coagulation, monopolar and bipolar cords (disposable and reusable), and Bankart Shoulder Repair Sets for open shoulder procedures. All instruments are manufactured to exacting standards for precision microsurgical use. Cords are noted for flexibility, suppleness, and durability, with support for multiple connection types including fixed pin and flying lead styles. The company targets surgical centers, hospitals, and specialty practices in demanding microsurgical applications.

Darleys Surgical Co. is a surgical instrument manufacturer and supplier specializing in hand-held surgical instruments, dental instruments, and instrument sets for multiple surgical specialties. The company manufactures a comprehensive range of stainless steel surgical instruments including forceps (extracting, artery), retractors, needle holders, curettes, elevators, and specialized cutting instruments. Product lines span general surgery, orthopedic surgery, obstetrics and gynecology, ENT procedures, and orthodontics. The company also produces "TC Instruments" (tungsten carbide), hollowares (surgical basins and trays), and complete surgical instrument sets for specialty procedures including laminectomy, coronary surgery, foot and ankle repair, and obstetrical procedures. Darleys maintains regulatory compliance with FDA, GMP, CE, ISO 13485 (Medical Devices Quality Management), and ISO 9001 (General Quality Management) certifications. The company exhibits at major medical trade shows including Medica (Düsseldorf) and FIME (Orlando). Products are identified by model numbers (DS-prefix) and are marketed globally through a distributor network. The company emphasizes rapid fulfillment and 24/7 customer service.

Pro-Tech International is a custom orthotics manufacturing facility established in 2003, specializing in the design and fabrication of custom orthoses for orthotists and medical professionals. The company manufactures custom spinal braces (including Cheneau/Rigo style braces) and lower-extremity devices (AFOs and other ankle-foot orthoses), serving orthotists and clinicians across North America. Pro-Tech operates as a B2B supplier providing fabrication services and finished orthotic devices to licensed orthotists and healthcare providers. The company emphasizes quality craftsmanship, clinical outcomes, and customer support, with long-standing relationships with orthotists (some spanning 20+ years). Manufacturing capabilities include custom spinal appliances and pediatric/adult lower-extremity orthoses. The facility is US-based and serves both domestic and international markets. Regulatory status and specific certifications (FDA, ISO 13485) are not explicitly detailed on the provided website content.

D&R Products is a contract manufacturer of medical devices headquartered in Hudson, Massachusetts, with over 80 years of continuous American manufacturing and 38 years of specialized focus on medical device outsourcing. The company operates a 43,000 square-foot facility providing turnkey manufacturing from bar stock to finished device. D&R holds ISO 13485-2016 certification and maintains in-house control over key manufacturing processes including CNC machining (Swiss turning, wire EDM), secondary operations (deburring, electropolishing, passivation, laser marking), precision welding (laser, palm arc, resistance), and clean room assembly (ISO Class 7 and 8). The company specializes in exotic materials including nitinol, titanium, stainless steel, and engineered polymers (PEAK, Radel). Product specialties include minimally invasive surgical devices, arthroscopic shaver blades and burrs, RF electrodes, soft tissue refixation implants, specialty needles, cannulas, and trocars. D&R maintains direct executive and engineering engagement for each customer project, offering design-for-manufacturability consultation and custom process development. The company reports being a sole-source supplier on over 75% of products and counts 6 of the 7 largest medical device companies among its customer base. Manufacturing capabilities span small lots through millions of units with documented traceability and quality system control.

Voiant is a clinical trial imaging Contract Research Organization (CRO) specializing in AI-powered imaging solutions for biopharmaceutical companies. With over 30 years of clinical expertise, Voiant delivers high-quality imaging endpoint data and endpoint adjudication services supporting therapies across oncology, ophthalmology, and respiratory indications from Phase I-IV global trials. The company operates a proprietary, purpose-built AI platform that accelerates imaging processing and analysis while maintaining scientific accuracy through expert human oversight. Voiant's services include independent reading center operations, blinded imaging review (BICR), and specialized imaging biomarker analysis. The company has expanded AI capabilities through acquisition of Voxeleron and maintains a global network of subspecialty-trained clinical readers, regulatory expertise, and over 2,700 registered clinical trial sites. Voiant has contributed to multiple FDA-approved therapies and serves as a trusted partner for sponsors, CROs, and clinical research organizations seeking reliable, reproducible imaging endpoint data and faster turnaround times.

Vericel Corporation manufactures and markets advanced cell therapy products for sports medicine and severe burn care in the United States. The company's primary product portfolio includes MACI (matrix-induced autologous chondrocyte implantation), an autologous cell therapy for repair of symptomatic knee cartilage defects using patient's own cells cultured on a porcine collagen membrane. MACI is now available with arthroscopic delivery (MACI Arthro) following FDA approval in August 2024, enabling minimally invasive treatment of full-thickness cartilage defects up to 4 cm². Epicel is Vericel's advanced cell therapy for severe burn care, utilizing autologous keratinocytes. The company also holds an exclusive license for North American commercial rights to NexoBrid® (anacaulase-bcdb), a biological orphan product approved for enzymatic eschar removal in deep partial-thickness and full-thickness thermal burns, with pediatric indication approved by the FDA in August 2024. All products are FDA-approved biologics. Vericel serves orthopedic surgeons, burn care specialists, and hospital systems across the United States. The company operates manufacturing and distribution capabilities supporting personalized cell therapy delivery.

Surgical Planning Associates (SPA) is a Boston-based medical technology company specializing in surgical navigation and preoperative planning solutions for orthopedic procedures. The company's flagship product, the HipInsight System, is the world's first FDA-cleared mixed reality navigation platform designed specifically for total hip arthroplasty. The system utilizes Microsoft HoloLens 2 mixed reality glasses to provide surgeons with real-time 3D holographic overlays of patient-specific anatomy, surgical instruments, and preoperative plans, effectively giving surgeons "x-ray vision" during surgery. HipInsight combines cloud-based preoperative planning with intraoperative guidance, achieving accuracy within 3 degrees of target anteversion and inclination. The platform integrates seamlessly into existing surgical workflows and can be deployed in under 5 minutes in the operating room. With over 11,000 hip replacement surgeries performed using SPA's technology across four continents, the company has established itself as a leader in digital surgery solutions. SPA maintains a co-marketing partnership with Zimmer Biomet and serves hospital systems and surgical centers seeking to improve implant positioning precision and surgical outcomes.

PHASE(n) is a Boston-based contract manufacturing and product development partner specializing in medical device design, process optimization, and second-source manufacturing. The firm provides extended R&D capability to medical device OEMs, supporting projects from concept through manufacturing scale-up. Core competencies include new product design, prototype development, process improvement, quality engineering, and cleanroom assembly. PHASE(n) has documented experience with RF electrodes, powered arthroscopic instruments, and sterile single-use and reusable medical accessories. The company emphasizes collaborative partnerships, cost containment, quality assurance, and accelerated scaling for growing medical device businesses. Services are structured to augment in-house R&D teams without requiring full-time headcount additions.

KYRA Medical, Inc. is a Massachusetts-based medical device manufacturer specializing in innovative patient positioning products for operating rooms. Founded in 2016, the company has developed a comprehensive portfolio of patented surgical positioning solutions designed to enhance surgical safety, minimize infection risk, and prevent nerve and tissue damage. Core products include lithotomy stirrups (Classic and Comfort lines), spine positioning frames (Curve and Connect systems), surgical armboards, and operating table accessories. Known for their signature purple stirrups, KYRA's solutions serve multiple surgical specialties including urology, gynecology, orthopedics, and spine surgery. The company holds over 30 patents and collaborates with 30+ OEM partners globally. With two global headquarters and five international service centers across five continents, KYRA delivers clinician-focused positioning innovations that standardize and simplify patient setup across diverse surgical procedures.