AVANTA ORTHOPAEDICS TENDON SPACER

K964359 · Avanta Orthopaedics, Inc. · HXA · Mar 25, 1997 · Orthopedic

Device Facts

• Record ID: K964359
• Device Name: AVANTA ORTHOPAEDICS TENDON SPACER
• Applicant: Avanta Orthopaedics, Inc.
• Product Code: HXA · Orthopedic
• Decision Date: Mar 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3025
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Surgical indications for the Avanta Orthopaedics Tendon Spacer include: Reconstruction of the flexor or extensor tendons of the fingers, thumb and wrist. Scared or adherent tendons following trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is a single-use, temporary implantation for 2-6 months.

Device Story

Silicone elastomer tendon spacer reinforced with dacron polyester mesh and suture; implanted surgically in hand/wrist to facilitate maturation of tendon bed; promotes growth of new tendon sheath; temporary implant (2-6 months); removed after bed maturation to allow gliding of tendon graft; not for permanent implantation or soft tissue ingrowth scaffold; used by orthopedic surgeons in clinical/OR settings; aids in restoring function to scarred or ruptured tendons.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Silicone elastomer; dacron polyester mesh and suture reinforcement; 3, 4, 5, 6 mm diameters; 24 cm length; single-use; temporary implant.

Indications for Use

Indicated for patients requiring reconstruction of flexor or extensor tendons in fingers, thumb, or wrist due to trauma, failed primary repair, absence of tendon sheath, scarred/adherent non-functional pulleys, or tendon rupture.

Regulatory Classification

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.

Predicate Devices

• Wright Silastic Tendon Spacer

Submission Summary (Full Text)

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K964359
MAR 25 1997

# 510(k) SUMMARY

| Submitter’s Name: | Avanta Orthopaedics
9369 Carroll Park Drive, Suite A
San Diego, CA 92121
619-452-8580 |
| --- | --- |
| Contact: | Louise Focht |
| Date of Preparation: | September 24, 1996 |
| Device Name: | Avanta Orthopaedics Tendon Spacer |
| Common Name: | Tendon Spacer |
| Predicate Device: | Wright Silastic Tendon Spacer |

## Device Description:

The Avanta Orthopaedics Tendon Spacer is a device intended to be implanted made of silicone elastomer which is reinforced with dacron polyester mesh and suture. The device is intended to be used in the surgical reconstruction of a flexor or extensor tendon of the hand. The device may be implanted long enough to permit maturation of the tendon bed to the point at which it can nourish and lubricate the gliding tendon graft. The device may be implanted for a period of time from 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 or to function as a scaffold for soft tissue ingrowth.

The tendon spacer will be available in four sizes, 3,4,5 and 6 mm diameter and 24 cm in length:

## Device Intended Use:

Surgical indications for the Avanta Orthopaedics Tendon Spacer include: Reconstruction of the flexor or extensor tendons of the fingers, thumb and wrist. Scared or adherent tendons following trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is a single-use, temporary implantation for 2-6 months.

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