Treace Medical Concepts, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Treace Medical Concepts, Inc.” (first 2015, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 30 days. Since 2017 the median was 30 days, against 96 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 80 |
| 2016 | 1 | 29 |
| 2017 | 1 | 55 |
| 2018 | 1 | 83 |
| 2019 | 3 | 56 |
| 2020 | 1 | 28 |
| 2021 | 1 | 30 |
| 2022 | 3 | 81 |
| 2023 | 2 | 137 |
| 2024 | 4 | 28 |
| 2025 | 1 | 129 |
| 2026 | 2 | 26 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Treace Medical Concepts, Inc. took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 11 | 11 |
| HWC | Screw, Fixation, Bone | 6 | 6 |
| JDR | Staple, Fixation, Bone | 4 | 4 |
Review panels
- Orthopedic (21)
Most recent Treace Medical Concepts, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262963 | TMC Implant Fixation System | HRS | 2026-09-15 | 21 |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | HWC | 2026-03-06 | 30 |
| K251135 | Treace Medical Concepts (TMC) Implant Fixation System | HRS | 2025-08-21 | 129 |
| K243658 | TMC Compression Implant System | JDR | 2024-12-26 | 29 |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation System | HWC | 2024-10-04 | 28 |
| K242415 | TMC Compression Implant System | JDR | 2024-09-06 | 22 |
| K240173 | Treace Medical Systems (TMC) Plating System | HRS | 2024-02-22 | 30 |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | JDR | 2023-08-28 | 19 |
| K221181 | Treace Medical Concepts (TMC) Plating System | HRS | 2023-01-05 | 255 |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation System | JDR | 2022-11-21 | 81 |
11 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-06-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Treace Medical Concepts, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06548581: The SpeedPlate™ Rapid Compression Implant Study (The SPRINT™ Study) (Active not recruiting, started 2024-09-04)
- NCT05587569: Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D) (Recruiting, started 2022-09-28)
- NCT03740282: Early Weight-Bearing After the Lapiplasty Procedure (Active not recruiting, started 2018-11-06)
SEC filings
TREACE MEDICAL CONCEPTS, INC. (TMCI): EDGAR filings, CIK 1630627. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Treace Medical, Inc. (80 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Treace Medical Concepts, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Treace Medical Concepts, Inc.” (first 2015, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Treace Medical Concepts, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Treace Medical Concepts, Inc. is 30 days. Since 2017: 30 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Treace Medical Concepts, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 11); HWC (Screw, Fixation, Bone, 6); JDR (Staple, Fixation, Bone, 4).
Next steps
- See all 21 Treace Medical Concepts, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Treace Medical Concepts, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.