Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tgm Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
187 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150576 | TGM Biolox delta Ceramic Heads | Tgm Medical, Inc. | 2015-09-09 | 187 | 0 |
| K130084 | MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, T | Tgm Medical, Inc. | 2013-05-03 | 109 | 0 |
| K121509 | TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, | Tgm Medical, Inc. | 2012-11-05 | 168 | 0 |
| K121636 | ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD | Tgm Medical, Inc. | 2012-10-24 | 142 | 0 |
| K112285 | MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZE | Tgm Medical, Inc. | 2011-11-04 | 87 | 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