JDJ · Mesh, Surgical, Acetabular, Hip, Prosthesis
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | JDJ |
|---|---|
| Device Name | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972760 | LINK, ACETABULAR REVISION MESH CUP | Link America, Inc. | Oct 22, 1997 | SESE |
| K970957 | OSTEONICS RESTORATION ACETABULAR RING | Osteonics Corp. | Jun 3, 1997 | SESE |
| K963940 | EXETER MESH | Howmedica, Inc. | Feb 13, 1997 | SESE |
| K962541 | REFLECTION ACETABULAR REINFORCEMENT RINGS | Smith & Nephew Richards, Inc. | Sep 17, 1996 | SESE |
| K962007 | PROTRUSION CAGES | Depuy, Inc. | Aug 1, 1996 | SESE |
| K925883 | OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS | Osteonics Corp. | Jun 15, 1993 | SESE |
| K890450 | INTERMEDICS APR(TM) II FEMORAL COMPONENT | Intermedics Orthopedics | Aug 9, 1989 | SN |
Top Applicants
- Osteonics Corp. — 2 clearances
- Smith & Nephew Richards, Inc. — 1 clearance
- Link America, Inc. — 1 clearance
- Intermedics Orthopedics — 1 clearance
- Howmedica, Inc. — 1 clearance
