Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hospital For Special Surgery · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942032 | PLAMP, PLAMP PLATE, PLAMP WITH HOOK | Hospital For Special Surgery | 1996-06-13 | 779 | 0 |
| K934857 | HSS FEMORAL COMPONENTS | Hospital For Special Surgery | 1995-07-18 | 644 | 0 |
| K935080 | INSALL-BURSTEIN II | Hospital For Special Surgery | 1995-05-22 | 574 | 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