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Data / Medical devices / United States / Treace Medical Concepts, Inc.

Treace Medical Concepts, Inc.: FDA-registered device maker in Ponte Vedra, FL, United States, 20 510(k) clearances

Treace Medical Concepts, Inc. is registered with the FDA (registration 3011623994) in Ponte Vedra, FL, United States. It lists 25 device types. The FDA files 20 510(k) clearances under its listings, the newest dated September 15, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Treace Medical Concepts, Inc.
FDA registration number
3011623994
Address
100 Palmetto Park Place, Ponte Vedra, FL, United States, 32081
Owner or operator
Treace Medical Concepts, Inc. (10050008)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 6, 2015
Registered through
2027
Brand names listed
Saw Blade

Devices it lists

DeviceProduct codeClassRoleSource
BenderHXW1Complaint file establishment, Specification developeraccessdata.fda.gov
Bit, DrillHTW1Complaint file establishment, Specification developeraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Manufactureraccessdata.fda.gov
BroachHTQ1Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Complaint file establishment, Specification developeraccessdata.fda.gov
CountersinkHWW1Complaint file establishment, Specification developeraccessdata.fda.gov
Gauge, DepthHTJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Manufactureraccessdata.fda.gov
Orthopaedic Surgical Planning And Instrument GuidesPBF2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Specification developeraccessdata.fda.gov
OsteotomeHWM1Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
RaspHTR1Manufactureraccessdata.fda.gov
RetractorGAD1Complaint file establishment, Specification developeraccessdata.fda.gov
Scalpel, One-PieceGDX1Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Complaint file establishment, Specification developeraccessdata.fda.gov
Staple, Fixation, BoneJDR2Manufactureraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Manufactureraccessdata.fda.gov
TampHXG1Complaint file establishment, Specification developeraccessdata.fda.gov
Tap, BoneHWX1Complaint file establishment, Specification developeraccessdata.fda.gov
TemplateHWT1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 15, 2026K262963TMC Implant Fixation SystemHRSSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
March 6, 2026K260361Treace Medical Concepts (TMC) Screw Fixation SystemHWCSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
August 21, 2025K251135Treace Medical Concepts (TMC) Implant Fixation SystemHRSSubstantially EquivalentTreace Medical Conceptsaccessdata.fda.gov
December 26, 2024K243658TMC Compression Implant SystemJDRSubstantially EquivalentTreace Medical Conceptsaccessdata.fda.gov
October 4, 2024K242671Treace Medical Concepts (TMC) Screw Fixation SystemHWCSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
September 6, 2024K242415TMC Compression Implant SystemJDRSubstantially EquivalentTreace Medical Conceptsaccessdata.fda.gov
February 22, 2024K240173Treace Medical Systems (TMC) Plating SystemHRSSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
August 28, 2023K232387Treace Medical Concepts (TMC) Compression Implant SystemJDRSubstantially EquivalentTreace Medical Conceptsaccessdata.fda.gov
November 21, 2022K222645Treace Medical Concepts (TMC) Implant Fixation SystemJDRSubstantially EquivalentTreace Medical Conceptsaccessdata.fda.gov
November 15, 2022K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemHWCSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
June 9, 2022K220717RedPoint Medical's Better Bunion SystemPBFSubstantially EquivalentRedpoint Medical, LLCaccessdata.fda.gov
February 16, 2022K220136Treace Medical Concepts (TMC) Plating SystemHRSSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
October 21, 2021K213036Treace Medical Concepts (TMC) Screw Fixation SystemHWCSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
May 8, 2020K200961Treace Medical Concepts (TMC) Plating SystemHRSSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
October 30, 2019K192504Treace Medical Concepts (TMC) Plating SystemHRSSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
June 13, 2019K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemHWCSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
January 25, 2019K183321Treace Medical Concepts (TMC) Plating SystemHRSSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
October 25, 2017K172617Treace Medical Concepts (TMC) Compression Screw SystemHWCSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
January 7, 2016K153531Treace Medical Concepts (TMC) Plating SystemHRSSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov
March 19, 2015K143717Treace Medical Concepts(TMC) Plating SystemHRSSubstantially EquivalentTreace Medical Concepts, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 2, 202494977Class IIOngoingNanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.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.accessdata.fda.gov

Compare with other makers

Updated September 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.