Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JDJ — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
208 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972760 | LINK, ACETABULAR REVISION MESH CUP | Link America, Inc. | 1997-10-22 | 90 | 0 |
| K970957 | OSTEONICS RESTORATION ACETABULAR RING | Osteonics Corp. | 1997-06-03 | 78 | 0 |
| K963940 | EXETER MESH | Howmedica, Inc. | 1997-02-13 | 135 | 0 |
| K962541 | REFLECTION ACETABULAR REINFORCEMENT RINGS | Smith & Nephew Richards, Inc. | 1996-09-17 | 81 | 0 |
| K962007 | PROTRUSION CAGES | Depuy, Inc. | 1996-08-01 | 71 | 0 |
| K925883 | OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS | Osteonics Corp. | 1993-06-15 | 208 | 0 |
| K890450 | INTERMEDICS APR(TM) II FEMORAL COMPONENT | Intermedics Orthopedics | 1989-08-09 | 191 | 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