Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Treace Medical Concepts · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
129 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2025-08-21 | 129 | 0 |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024-12-26 | 29 | 0 |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024-09-06 | 22 | 0 |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | 2023-08-28 | 19 | 0 |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2022-11-21 | 81 | 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