MODIFICATION TO DEPUY NEUFLEX PIP FINGER
FDA 510(k) clearance K083107 · decided 2009-02-09
Clearance details
- K-number
- K083107
- Device name
- MODIFICATION TO DEPUY NEUFLEX PIP FINGER
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-20
- Decision date
- 2009-02-09
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- KYJ
- Device class
- 2
- Regulation number
- 888.3230
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ascension Silicone MCP; Ascension Silicone PIP (K233670) | Ascension Orthopedics, Inc. | 2023-12-14 |
| BRM Digitalis Spacer (K220142) | Brm Extremities Srl | 2023-04-04 |
| KeriFlex® MCP and PIP Finger Joint Prostheses (K211385) | Keri Medical SA | 2022-07-27 |
| OSTEOTEC SILICONE FINGER IMPLANT (K140453) | Osteotec, Ltd. | 2015-04-17 |
| ASCENSION SILICONE PIP (K082231) | Ascension Orthopedics, Inc. | 2009-01-12 |
| ASCENSION SILLICONE MCP (K022892) | Ascension Orthopedics, Inc. | 2002-11-25 |
| FINGER JOINT PROSTHESIS (K013629) | Avanta Orthopaedics, Inc. | 2002-01-25 |
| DEPUY NEUFLEX PIP FINGER (K001922) | Depuy, Inc. | 2000-08-29 |
| DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS (K970544) | Depuy, Inc. | 1997-09-12 |
| SUTTER PROXIMAL INTERPHALANGEAL JOINT (K931588) | Sutter Corp. | 1994-03-10 |
| SUTTER FINGER JOINT PROSTHESIS (K870200) | Sutter Biomedical, Inc. | 1987-10-09 |
| MARNE M.T.P.J. ORTHOPEDIC IMPLANT (K781380) | Farah , Ltd. | 1979-02-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ceramax Ceramic Hip System (P070026/S123) | DePuy Orthopaedics, Inc. | 2025-12-09 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S121) | DePuy Orthopaedics, Inc. | 2025-08-05 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S122) | DePuy Orthopaedics, Inc. | 2025-08-01 |
| CERAMAX® ceramic total hip system (P070026/S120) | DePuy Orthopaedics, Inc. | 2025-06-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S119) | DePuy Orthopaedics, Inc. | 2025-04-04 |
| DePuy Ceramax Ceramic Total Hip System (P070026/S114) | DePuy Orthopaedics, Inc. | 2025-03-19 |
| Ceramax Ceramic Hip System (P070026/S117) | DePuy Orthopaedics, Inc. | 2025-02-21 |
| Ceramax® Ceramic Total Hip System (P070026/S116) | DePuy Orthopaedics, Inc. | 2025-02-11 |