KYJ · Prosthesis, Finger, Constrained, Polymer
Orthopedic · 21 CFR 888.3230 · Class 2
Overview
| Product Code | KYJ |
|---|---|
| Device Name | Prosthesis, Finger, Constrained, Polymer |
| Regulation | 21 CFR 888.3230 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.
Classification Rationale
Class II.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233670 | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | Dec 14, 2023 | SESE |
| K220142 | BRM Digitalis Spacer | Brm Extremities Srl | Apr 4, 2023 | SESE |
| K211385 | KeriFlex® MCP and PIP Finger Joint Prostheses | Keri Medical SA | Jul 27, 2022 | SESE |
| K140453 | OSTEOTEC SILICONE FINGER IMPLANT | Osteotec, Ltd. | Apr 17, 2015 | SESE |
| K083107 | MODIFICATION TO DEPUY NEUFLEX PIP FINGER | DePuy Orthopaedics, Inc. | Feb 9, 2009 | SESE |
| K082231 | ASCENSION SILICONE PIP | Ascension Orthopedics, Inc. | Jan 12, 2009 | SESE |
| K022892 | ASCENSION SILLICONE MCP | Ascension Orthopedics, Inc. | Nov 25, 2002 | SESE |
| K013629 | FINGER JOINT PROSTHESIS | Avanta Orthopaedics, Inc. | Jan 25, 2002 | SESE |
| K001922 | DEPUY NEUFLEX PIP FINGER | Depuy, Inc. | Aug 29, 2000 | SESE |
| K970544 | DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS | Depuy, Inc. | Sep 12, 1997 | SESE |
| K931588 | SUTTER PROXIMAL INTERPHALANGEAL JOINT | Sutter Corp. | Mar 10, 1994 | SESE |
| K870200 | SUTTER FINGER JOINT PROSTHESIS | Sutter Biomedical, Inc. | Oct 9, 1987 | SESE |
| K781380 | MARNE M.T.P.J. ORTHOPEDIC IMPLANT | Farah , Ltd. | Feb 21, 1979 | SESE |
| K781668 | GAMMA RADIATION STERILIZATION PRECEDURE | Cutter Laboratories, Inc. | Nov 3, 1978 | SESE |
Top Applicants
- Ascension Orthopedics, Inc. — 3 clearances
- Depuy, Inc. — 2 clearances
- Avanta Orthopaedics, Inc. — 1 clearance
- Brm Extremities Srl — 1 clearance
- Cutter Laboratories, Inc. — 1 clearance
