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Public medical device manufacturer focused on bunion correction and other foot and ankle procedures.
Treace Medical Concepts (Nasdaq: TMCI) develops and markets instruments, implants and procedure systems for foot and ankle surgery. Based in Ponte Vedra, Florida, it commenced business in 2013 and began focusing on foot and ankle in 2014. Its current portfolio includes Lapiplasty and Adductoplasty, minimally invasive bunion systems, compression implants and screws, patient-specific guides, and graft products.
The business combines implant sales with surgeon education, procedural support and patient-facing awareness. It reported second-quarter 2026 revenue of $45.4 million, down 4% from a year earlier, and a $15.9 million net loss. Recent commercialization activity includes SuperBite compression screws and HyperPlate XM. Product availability ranges from established offerings to limited market releases; a catalog listing does not establish uniform availability.
Clinical evidence includes prospective post-market studies and peer-reviewed publications. A four-year Lapiplasty cohort reported follow-up for 139 of 173 treated patients, with outcomes varying by recurrence definition. The company announced five-year ALIGN3D results in September 2026. These observational findings should not be treated as randomized proof of superiority. FDA clearance, product claims and clinical outcomes are distinct; the profile also identifies an open recall affecting a specific Nanoplasty kit.
The filing describes manufactured devices as Class II FDA-cleared or Class I exempt. Current devices and grafts do not all share one regulatory pathway. The scorecard counts unique FDA decisions associated with current families, including earlier family decisions; a product brand or exempt instrument does not automatically add a clearance. [37][64][65][68][11][3][69][70][2]
The matched FDA history contains 1 distinct recall event: 1 open, 0 terminated. 1 were initiated during the five years beginning October 20, 2021; older open events are also retained. Z-2718-2024 (2024-06-02; open, classified): Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates. [29]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Current biplanar plating and implant fixation family supporting foot correction and fusion procedures, including Lapiplasty variants. [69]
FDA-clearedListed in current U.S. company catalog; availability and release extent vary by product.
Compression and fixation screw family used in foot surgery; includes current compression screw offerings. Exact brand-to-clearance mapping remains under review. [66]
FDA-clearedListed in current U.S. company catalog; availability and release extent vary by product.
Current compression implant platform including SpeedPlate, SpeedMTP, SpeedTMT and SpeedAkin offerings. FDA decisions are counted once across the shared family. [64]
FDA-clearedListed in current U.S. company catalog; availability and release extent vary by product.
Hammertoe fixation system listed in the current company site navigation. [64]
FDA-clearedListed in current U.S. company catalog; availability and release extent vary by product.
Current minimally invasive bunion correction system; specific SK57 implant kit is associated with an open FDA recall. [64]
FDA-clearedListed in current U.S. company catalog; availability and release extent vary by product.
Current instrumented midfoot correction procedures and associated devices. [64]
Marketed · regulatory scope variesListed in current U.S. company catalog; availability and release extent vary by product.
CT-based preoperative planning and patient-specific cut guides. Company describes these under 21 CFR 888.3030; not counted as an extra clearance merely because of a new brand. [68]
Marketed · regulatory scope variesListed in current U.S. company catalog; availability and release extent vary by product.
Current percutaneous bunion correction offering. [64]
Marketed · regulatory scope variesListed in current U.S. company catalog; availability and release extent vary by product.
Current midfoot and hindfoot fixation offering. Initial clinical case reported during second quarter 2026. [67]
Marketed · regulatory scope variesListed in current U.S. company catalog; availability and release extent vary by product.
Current compression screw offering, initially placed in limited market release in second quarter 2026. [70]
Marketed · regulatory scope variesListed in current U.S. company catalog; availability and release extent vary by product.
Includes CartiBlaster rasps, GreatRelease XM, CurvedTritome and BarrelReamer in the current catalog. [64]
Marketed · regulatory scope variesListed in current U.S. company catalog; availability and release extent vary by product.
VitaFuse bioactive glass, CortiFuse cortical fibers and allograft wedges. Manufacturer attribution includes Berkeley Advanced Biomaterials and Origin Biologics; third-party regulatory mapping is incomplete. [65]
Marketed · regulatory scope variesListed in current U.S. company catalog; availability and release extent vary by product.
New product work and clinical follow-up continue alongside commercial sales. SuperBite and HyperPlate XM are treated as commercial release activity where documented, rather than inflated into separate unapproved pipeline products. No complete, separately enumerated development pipeline was established. [35][64]
The company reported five-year analysis for 137 of 173 treated patients, with recurrence varying by radiographic definition. Results were conference-reported; an observational cohort does not establish superiority over competing procedures. [33]
Treace reported Q2 revenue of $45.4 million versus $47.4 million a year earlier, a $15.9 million net loss and $45.6 million in cash, cash equivalents and marketable securities at June 30. [35]
The quarterly report described limited release of SuperBite and the first HyperPlate XM surgical case. These are commercialization milestones, not separate FDA approvals. [35]
FDA event 94977 concerns a specific SK57 kit containing a metatarsal plate; the FDA record remains open. See public recall information for scope. [61]
FDA cleared K143717, an early decision in the TMC plating family. This is an authorization milestone, not a product launch date. [39]
The 2025 Form 10-K states the business commenced in July 2013 and began focusing on foot and ankle in January 2014. [37]
Accessed 10/29/2026