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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets
The Directory // Orthopedics & Spine

Orthopedics & Spine

Implants, biologics, spine hardware and sports medicine. 30 companies listed.

Boca Raton, FL  ·  Est. 2025  ·  Unknown  ·  510(k) cleared

Sells the Vantage Lumbar Decompression Kit, a fully disposable sterile system for minimally invasive laminotomy and laminectomy with depth-controlled bone removal and integrated illumination. SurGenTec took exclusive rights to the system in October 2026.

Orlando, FL  ·  Unknown  ·  510(k) cleared

Orlando, Florida orthopedic startup making a sutureless PEEK tendon anchor for soft tissue to bone fixation. Its first 510(k), K252635, was cleared in May 2026 for biceps tenodesis, and a second clearance announced in September 2026 added lateral extra-articular tenodesis in the knee.

Chicago, IL  ·  Est. 2014  ·  Series D+  ·  $148M raised  ·  510(k) cleared

Builds xvision, an augmented reality navigation system for spine surgery that projects CT anatomy onto a headset the surgeon wears. Its second generation X2 headset was cleared in 2025.

Atlanta, GA  ·  Unknown  ·  510(k) cleared

Makes NerveTape, a sutureless device that joins two cut nerve ends with microhooks embedded in porcine submucosa. Axogen agreed to buy the company for $200 million in cash in September 2026.

Cambridge, MA  ·  Series B  ·  De Novo granted

Cambridge, Massachusetts spin-out from Mass General Brigham developing ReneuRx (Neural Ice), an injectable, drug-free thermal nerve block for musculoskeletal pain. FDA granted De Novo DEN250067 on August 21, 2026, creating product code SJA under 21 CFR 888.3048.

Carlsbad, CA  ·  Est. 2018  ·  Public  ·  510(k) cleared

Builds aprevo, patient-specific spinal interbody implants made from preoperative planning software, plus the single-use instruments that place them. Cleared for lumbar and cervical fusion.

Naples, FL  ·  Est. 2014  ·  Unknown  ·  510(k) cleared

Shoulder replacement systems only, including anatomic, reverse, stemmed and fracture implants plus the Archer 3D targeting software. Founded by an orthopedic surgeon.

Memphis, TN  ·  Pre-seed  ·  In development

Developing a modular shoulder implant system that lets a surgeon switch between anatomic and reverse configurations.

Kirkland, WA  ·  510(k) cleared

Makes curved intramedullary implants for pelvic fracture fixation. Sells the CurvaFix IM System and a Low Profile version with a smaller implant head.

Grenoble, France  ·  Est. 2009  ·  Acquired  ·  510(k) cleared

Builds the Op.n surgical platform, which combines 2D and 3D imaging, navigation and robotic guidance for spine and orthopedic procedures, and is open to third party implants and applications. Enovis agreed to acquire the company in September 2026.

San Carlos, CA  ·  Series B  ·  PMA approved

Empirical Spine makes LimiFlex, a tension band implanted after lumbar decompression to stabilize the segment without fusion. The device came out of Stanford Biodesign and has a 2009 CE mark.

San Francisco, CA  ·  Series A  ·  $22.5M raised  ·  Not a regulated device

Vertically integrated durable medical equipment company. It handles insurance approval, point-of-care scanning and ordering, and 3D-printed manufacturing of custom orthotics and prosthetics in its own lab.

Stockholm, Sweden  ·  Seed  ·  CE mark

Develops bone cement products for osteoporotic bone, including a cement softener additive and V-Flex, a cement formulated for vertebral augmentation.

West Chester, PA  ·  Est. 2016  ·  Series B  ·  510(k) cleared

Makes a flexible nitinol intramedullary implant for long-bone fracture fixation in adults and children. Cleared under K250316 in October 2025 and in a controlled alpha launch.

Westborough, MA  ·  Series B  ·  De Novo granted

Makes the BEAR Implant, a collagen scaffold that lets a torn ACL heal rather than being replaced with a graft. The surgeon injects the patient's own blood into the implant before placing it.

Marietta, GA  ·  Est. 2016  ·  Growth  ·  510(k) cleared

Builds spine and orthopedic implants from molybdenum-rhenium alloys, with 24 510(k) clearances, and is developing SIEGEL, a nickel-free balloon-expandable TAVR valve in the STAR trial. Boston Scientific owns about 34% after a $1.5B investment in May 2026.

Claymont, DE  ·  Unknown  ·  510(k) cleared

Makes NextMR, software that generates 3D bone visualization of the lumbar spine and sacrum from a standard diagnostic MRI, removing the need for a separate CT scan.

Utrecht, Netherlands  ·  Unknown  ·  510(k) cleared

BoneMRI software builds a CT-like 3D view of bone from an MRI scan, so bone structures can be read and surgical plans made without the radiation dose. A University of Utrecht spin-off.

Providence, RI  ·  Est. 2024  ·  Unknown  ·  510(k) cleared

Soft tissue fixation company with two cleared products: Repair Construct, a knotless suture fixation device adjustable during surgery, and Native Bridge for bone-to-bone fixation.

Dayton, OH  ·  Est. 2023  ·  Unknown  ·  510(k) cleared

Spine implant company whose first cleared product is the MOD-C cervical implant.

Seed  ·  Breakthrough designation

Develops a minimally invasive artificial meniscus implant meant to restore knee cushioning after meniscus injury and delay joint replacement.

Nashville, TN  ·  Pre-seed  ·  In development

Builds augmented reality smart glasses that turn a patient's medical scans into a 3D model for intraoperative guidance during knee replacement.

Est. 2023  ·  Pre-seed  ·  $10M raised  ·  In development

Computer-vision navigation for orthopedic surgery that registers without fiducials or arrays, built as the intelligence layer for later robotic systems. First application is shoulder arthroplasty.

North Dakota  ·  Pre-seed  ·  In development

Developing a toolset and implant system for spinal procedures done in outpatient pain clinics, aimed at early to mid stage chronic pain. The instruments are manual rather than powered.

Dallas, TX  ·  Est. 2019  ·  Unknown  ·  In development

Treats periprosthetic joint infection with alternating magnetic fields that heat the outer surface of a metal implant and disrupt bacterial biofilm. The goal is to clear the infection without explanting the joint.

Louisville, CO  ·  Series A  ·  PMA approved

Synergy Spine Solutions makes the Synergy Disc, a cervical artificial disc with a lordotic core meant to restore alignment while preserving motion. It has sold outside the US since 2009.

Fremont, CA  ·  Growth  ·  510(k) cleared

Builds TMINI, a cordless handheld robotic system for total knee replacement that works from a CT based 3D plan and guides bone pin placement.

Houston, TX  ·  Est. 2020  ·  Unknown

Makes a hydrogel coating applied to tendons during surgery to limit internal scarring after tendon and ligament repair.

Orlando, FL  ·  Unknown  ·  510(k) cleared

Makes spine implants, including the Riva posterior and spinopelvic fixation systems and the Lux expandable lumbar interbody cage. Its implants use a proprietary micro and nano scale surface texture called NanoACTIV.

Zurich, Switzerland  ·  Acquired  ·  510(k) cleared

Zurich company behind the FiberLocker system, a mechanical rotator cuff augmentation that interweaves patch fibers into tendon tissue. FiberLocker received FDA clearance in February 2025, and Stryker signed a definitive agreement to acquire the company on August 31, 2026.

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