← Product Code [HSD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD) · K791548

# REXTON HS(HEARING SYSTEM) (K791548)

_Argosy Intl. (Usa), Inc. · HSD · Sep 28, 1979 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K791548

## Device Facts

- **Applicant:** Argosy Intl. (Usa), Inc.
- **Product Code:** [HSD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD.md)
- **Decision Date:** Sep 28, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3690
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K791548](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K791548)

**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