← Product Code [HSH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSH) · K003269

# UNICONDYLAR INTERPOSITIONAL SPACER (K003269)

_Sulzer Orthopedics, Inc. · HSH · Jan 4, 2001 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSH/K003269

## Device Facts

- **Applicant:** Sulzer Orthopedics, Inc.
- **Product Code:** [HSH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSH.md)
- **Decision Date:** Jan 4, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3590
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSH/K003269](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSH/K003269)

**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