← Product Code [KWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH) · K943354

# SUTTER HAMMERTOE JOINT PROSTHESIS (K943354)

_Sutter Corp. · KWH · Jun 12, 1995 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K943354

## Device Facts

- **Applicant:** Sutter Corp.
- **Product Code:** [KWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH.md)
- **Decision Date:** Jun 12, 1995
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K943354](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K943354)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com