← Product Code [HXA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA) · K930125

# PHOENIX BONE SCREWS PBS-TYPE SERIES (K930125)

_Phoenix Bioengineering, Inc. · HXA · Dec 30, 1993 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K930125

## Device Facts

- **Applicant:** Phoenix Bioengineering, Inc.
- **Product Code:** [HXA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA.md)
- **Decision Date:** Dec 30, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3025
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K930125](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K930125)

**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