← Product Code [KWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH) · K820813

# LESSER METATARSAL PHALANG. JOINT PROSTH (K820813)

_Sutter Biomedical, Inc. · KWH · May 21, 1982 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K820813

## Device Facts

- **Applicant:** Sutter Biomedical, Inc.
- **Product Code:** [KWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH.md)
- **Decision Date:** May 21, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3720
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K820813](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K820813)

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