JDJ
7 FDA 510(k) clearances · Product code
90 daysmedian time to decision
208 days90th percentile
7clearances measured
FDA profile
- Official device name
- Mesh, Surgical, Acetabular, Hip, Prosthesis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- Adverse events (MAUDE)
- 2014: 15 · 2015: 12 · 2018: 15 · 2019: 34 · 2020: 14 · 2021: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LINK, ACETABULAR REVISION MESH CUP (K972760) | Link America, Inc. | 1997-10-22 |
| OSTEONICS RESTORATION ACETABULAR RING (K970957) | Osteonics Corp. | 1997-06-03 |
| EXETER MESH (K963940) | Howmedica, Inc. | 1997-02-13 |
| REFLECTION ACETABULAR REINFORCEMENT RINGS (K962541) | Smith & Nephew Richards, Inc. | 1996-09-17 |
| PROTRUSION CAGES (K962007) | Depuy, Inc. | 1996-08-01 |
| OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS (K925883) | Osteonics Corp. | 1993-06-15 |
| INTERMEDICS APR(TM) II FEMORAL COMPONENT (K890450) | Intermedics Orthopedics | 1989-08-09 |
Track JDJ automatically
Every clearance here is in the API, with alerts when new ones post.