← Product Code [HXA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA) · K780320

# PASSIVE TENDON IMPLANT (K780320)

_Holter-Hausner Intl. · HXA · Mar 17, 1978 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K780320

## Device Facts

- **Applicant:** Holter-Hausner Intl.
- **Product Code:** [HXA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA.md)
- **Decision Date:** Mar 17, 1978
- **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.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K780320](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K780320)

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