Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3230](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3230) → KYJ — Prosthesis, Finger, Constrained, Polymer

# KYJ · Prosthesis, Finger, Constrained, Polymer

_Orthopedic · 21 CFR 888.3230 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ

## Overview

- **Product Code:** KYJ
- **Device Name:** Prosthesis, Finger, Constrained, Polymer
- **Regulation:** [21 CFR 888.3230](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3230)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K233670.md) | Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. | Dec 14, 2023 | SESE |
| [K220142](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K220142.md) | BRM Digitalis Spacer | Brm Extremities Srl | Apr 4, 2023 | SESE |
| [K211385](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K211385.md) | KeriFlex® MCP and PIP Finger Joint Prostheses | Keri Medical SA | Jul 27, 2022 | SESE |
| [K140453](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K140453.md) | OSTEOTEC SILICONE FINGER IMPLANT | Osteotec, Ltd. | Apr 17, 2015 | SESE |
| [K083107](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K083107.md) | MODIFICATION TO DEPUY NEUFLEX PIP FINGER | DePuy Orthopaedics, Inc. | Feb 9, 2009 | SESE |
| [K082231](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K082231.md) | ASCENSION SILICONE PIP | Ascension Orthopedics, Inc. | Jan 12, 2009 | SESE |
| [K022892](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K022892.md) | ASCENSION SILLICONE MCP | Ascension Orthopedics, Inc. | Nov 25, 2002 | SESE |
| [K013629](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K013629.md) | FINGER JOINT PROSTHESIS | Avanta Orthopaedics, Inc. | Jan 25, 2002 | SESE |
| [K001922](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K001922.md) | DEPUY NEUFLEX PIP FINGER | Depuy, Inc. | Aug 29, 2000 | SESE |
| [K970544](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K970544.md) | DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS | Depuy, Inc. | Sep 12, 1997 | SESE |
| [K931588](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K931588.md) | SUTTER PROXIMAL INTERPHALANGEAL JOINT | Sutter Corp. | Mar 10, 1994 | SESE |
| [K870200](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K870200.md) | SUTTER FINGER JOINT PROSTHESIS | Sutter Biomedical, Inc. | Oct 9, 1987 | SESE |
| [K781380](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K781380.md) | MARNE M.T.P.J. ORTHOPEDIC IMPLANT | Farah , Ltd. | Feb 21, 1979 | SESE |
| [K781668](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ/K781668.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYJ)

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