Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3025](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3025) → HXA — Prosthesis, Tendon, Passive

# HXA · Prosthesis, Tendon, Passive

_Orthopedic · 21 CFR 888.3025 · Class 2_

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

## Overview

- **Product Code:** HXA
- **Device Name:** Prosthesis, Tendon, Passive
- **Regulation:** [21 CFR 888.3025](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3025)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243477](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K243477.md) | Universal Tendon Spacer | Askorn Medical | Jan 10, 2025 | SESE |
| [K000019](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K000019.md) | SINGLE SIZE TENDON SPACER | Medist International | Mar 29, 2000 | SESE |
| [K973385](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K973385.md) | OVAL SHAPES | Technical Products, Inc. | Dec 5, 1997 | SESE |
| [K964359](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K964359.md) | AVANTA ORTHOPAEDICS TENDON SPACER | Avanta Orthopaedics, Inc. | Mar 25, 1997 | SESE |
| [K930125](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K930125.md) | PHOENIX BONE SCREWS PBS-TYPE SERIES | Phoenix Bioengineering, Inc. | Dec 30, 1993 | SESE |
| [K872293](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K872293.md) | H-H HUNTER ACTIVE TENDON IMPLANT BC | Holter-Hausner Intl. | Sep 28, 1987 | SN |
| [K872285](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K872285.md) | H-H HUNTER ACTIVE TENDON IMPLANT DC | Holter-Hausner Intl. | Sep 28, 1987 | SN |
| [K872284](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K872284.md) | H-H HUNTER ACTIVE TENDON IMPLANT PC | Holter-Hausner Intl. | Sep 28, 1987 | SN |
| [K853438](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K853438.md) | H-H HUNTER ACTIVE TENDON IMPLANT | Holter-Hausner Intl. | Sep 30, 1985 | SN |
| [K781943](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K781943.md) | TENDON ROD MODEL OR41PO3-6 | Holter-Hausner Intl. | Dec 4, 1978 | SESE |
| [K780320](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HXA/K780320.md) | PASSIVE TENDON IMPLANT | Holter-Hausner Intl. | Mar 17, 1978 | SESE |

## Top Applicants

- Holter-Hausner Intl. — 6 clearances
- Askorn Medical — 1 clearance
- Avanta Orthopaedics, Inc. — 1 clearance
- Medist International — 1 clearance
- Phoenix Bioengineering, Inc. — 1 clearance

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

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