Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novosource, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140701 | NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ H | Novosource, Inc. | 2014-06-27 | 99 | 0 |
| K132158 | NOVOHIP TOTAL HIP SYSTEM | Novosource, Inc. | 2014-02-21 | 224 | 1 |
| K131398 | NOVOKNEE TOTAL KNEE SYSTEM | Novosource, Inc. | 2013-09-16 | 124 | 0 |
| K123339 | TK1 TOTAL KNEE SYSTEM | Novosource, Inc. | 2013-04-11 | 162 | 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