Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Treace Medical Concepts, Inc. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
191 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026-03-06 | 30 | 0 |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2024-10-04 | 28 | 0 |
| K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024-02-22 | 30 | 1 |
| K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023-01-05 | 255 | 0 |
| K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System | Treace Medical Concepts, Inc. | 2022-11-15 | 83 | 0 |
| K220136 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2022-02-16 | 29 | 0 |
| K213036 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2021-10-21 | 30 | 0 |
| K200961 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2020-05-08 | 28 | 0 |
| K192504 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2019-10-30 | 48 | 0 |
| K183363 | Treace Medical Concepts (TMC) Snap-Off Screw System | Treace Medical Concepts, Inc. | 2019-06-13 | 191 | 0 |
| K183321 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2019-01-25 | 56 | 0 |
| K173930 | PYTHON Plate Trial Instruments | Treace Medical Concepts, Inc. | 2018-03-19 | 83 | 0 |
| K172617 | Treace Medical Concepts (TMC) Compression Screw System | Treace Medical Concepts, Inc. | 2017-10-25 | 55 | 0 |
| K153531 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2016-01-07 | 29 | 0 |
| K143717 | Treace Medical Concepts(TMC) Plating System | Treace Medical Concepts, Inc. | 2015-03-19 | 80 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda