HXA · Prosthesis, Tendon, Passive
Orthopedic · 21 CFR 888.3025 · Class 2
Overview
| Product Code | HXA |
|---|---|
| Device Name | Prosthesis, Tendon, Passive |
| Regulation | 21 CFR 888.3025 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 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 | Universal Tendon Spacer | Askorn Medical | Jan 10, 2025 | SESE |
| K000019 | SINGLE SIZE TENDON SPACER | Medist International | Mar 29, 2000 | SESE |
| K973385 | OVAL SHAPES | Technical Products, Inc. | Dec 5, 1997 | SESE |
| K964359 | AVANTA ORTHOPAEDICS TENDON SPACER | Avanta Orthopaedics, Inc. | Mar 25, 1997 | SESE |
| K930125 | PHOENIX BONE SCREWS PBS-TYPE SERIES | Phoenix Bioengineering, Inc. | Dec 30, 1993 | SESE |
| K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC | Holter-Hausner Intl. | Sep 28, 1987 | SN |
| K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC | Holter-Hausner Intl. | Sep 28, 1987 | SN |
| K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC | Holter-Hausner Intl. | Sep 28, 1987 | SN |
| K853438 | H-H HUNTER ACTIVE TENDON IMPLANT | Holter-Hausner Intl. | Sep 30, 1985 | SN |
| K781943 | TENDON ROD MODEL OR41PO3-6 | Holter-Hausner Intl. | Dec 4, 1978 | SESE |
| K780320 | 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
