Treace Medical Concepts, Inc.
Ponte Vedra, FL, US
TREACE MEDICAL CONCEPTS, INC. appears in FDA device records in Ponte Vedra, FL. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for Treace Medical Concepts, Inc. between 2015 and 2026. The busiest year on record is 2024, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | HWC | Substantially Equivalent | |
| K251135 | Treace Medical Concepts (TMC) Implant Fixation System | HRS | Substantially Equivalent | |
| K243658 | TMC Compression Implant System | JDR | Substantially Equivalent | |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation System | HWC | Substantially Equivalent | |
| K242415 | TMC Compression Implant System | JDR | Substantially Equivalent | |
| K240173 | Treace Medical Systems (TMC) Plating System | HRS | Substantially Equivalent | |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | JDR | Substantially Equivalent | |
| K221181 | Treace Medical Concepts (TMC) Plating System | HRS | Substantially Equivalent | |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation System | JDR | Substantially Equivalent | |
| K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System | HWC | Substantially Equivalent | |
| K220136 | Treace Medical Concepts (TMC) Plating System | HRS | Substantially Equivalent | |
| K213036 | Treace Medical Concepts (TMC) Screw Fixation System | HWC | Substantially Equivalent | |
| K200961 | Treace Medical Concepts (TMC) Plating System | HRS | Substantially Equivalent | |
| K192504 | Treace Medical Concepts (TMC) Plating System | HRS | Substantially Equivalent | |
| K183363 | Treace Medical Concepts (TMC) Snap-Off Screw System | HWC | Substantially Equivalent | |
| K183321 | Treace Medical Concepts (TMC) Plating System | HRS | Substantially Equivalent | |
| K173930 | PYTHON Plate Trial Instruments | HRS | Substantially Equivalent | |
| K172617 | Treace Medical Concepts (TMC) Compression Screw System | HWC | Substantially Equivalent | |
| K153531 | Treace Medical Concepts (TMC) Plating System | HRS | Substantially Equivalent | |
| K143717 | Treace Medical Concepts(TMC) Plating System | HRS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011623994 | 3011623994 | TREACE MEDICAL CONCEPTS, INC. | 100 Palmetto Park Place, PONTE VEDRA, FL 32081 US | 2026 | and 15 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HXWBender
- HTWBit, Drill
- GFABlade, Saw, General & Plastic Surgery, Surgical
- HTQBroach
- FZOChisel, Surgical, Manual
- HWWCountersink
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- HWNInstrument, Compression
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- PBFOrthopaedic Surgical Planning And Instrument Guides
- LXHOrthopedic Manual Surgical Instrument
- HWMOsteotome
- HRSPlate, Fixation, Bone
- HTRRasp
- GADRetractor
- GDXScalpel, One-Piece
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- JDRStaple, Fixation, Bone
- LMDSystem, Digital Image Communications, Radiological
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2718-2024 | Nanoplasty 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain