Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Theken Companies, LLC · 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) |
|---|---|---|---|---|---|
| K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | 2019-09-17 | 126 | 1 |
| K192071 | iNSitu Total Hip System | Theken Companies, LLC | 2019-08-30 | 28 | 0 |
| K172501 | iNSitu Total Hip System | Theken Companies, LLC | 2017-09-21 | 34 | 0 |
| K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016-10-14 | 170 | 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