Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Encore Medical, L.P. (Dba Enovis) · 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) |
|---|---|---|---|---|---|
| K240324 | EMPOWR Revision Symmetric Knee Cones | Encore Medical, L.P. (Dba Enovis) | 2024-04-26 | 84 | 0 |
| K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial | Encore Medical, L.P Dba Enovis | 2023-04-06 | 76 | 0 |
| K230441 | EMPOWR Stem Extender, 50mm | Encore Medical, L.P Dba Enovis | 2023-03-17 | 24 | 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