AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT

K964381 · Avanta Orthopaedics, Inc. · KYI · Jan 22, 1997 · Orthopedic

Device Facts

• Record ID: K964381
• Device Name: AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT
• Applicant: Avanta Orthopaedics, Inc.
• Product Code: KYI · Orthopedic
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Avanta Orthopaedics Trapezial Implant is a device intended to be implanted in the trapezial bone of the wrist. It is made of molded silicone elastomer. The device is intended to be used in the treatment of thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint of the thumb or thumb and index finger in combination. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity.

Device Story

Trapezial implant; molded silicone elastomer; surgically implanted in wrist trapezial bone. Treatment for thumb disabilities (osteoarthritis, post-traumatic arthritis, rheumatoid arthritis). Addresses pain, crepitation, loss of motion, reduced grip/pinch strength, and joint instability. Used by orthopedic surgeons in clinical/surgical settings. Provides structural replacement/support for damaged trapeziometacarpal joint; restores thumb function; improves patient quality of life.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Molded silicone elastomer; trapezial implant form factor; surgical implantation.

Indications for Use

Indicated for patients with thumb disabilities due to osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis presenting with localized pain, crepitation during circumduction, loss of motion, decreased pinch/grip strength, radiological evidence of trapeziometacarpal joint arthritis, or unstable/stiff distal thumb joints/swan-neck deformity.

Regulatory Classification

Identification

A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.

Predicate Devices

• Dow Corning Corporation Silastic H.P. Trapezial Implant

Submission Summary (Full Text)

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510(k) SUMMARY
K964381
JAN 22 1997

Submitter's Name:
Avanta Orthopaedics
9369 Carroll Park Drive, Suite A
San Diego, CA 92121
619-452-8580

Contact: Louise Focht
Date of Preparation: November 1, 1996
Device Name: Avanta Orthopaedics Trapezial Implant
Common Name: Trapezial Implant
Predicate Device: Dow Corning Corporation Silastic H.P.
Trapezial Implant

Device Description:

The Avanta Orthopaedics Trapezial Implant is a device intended to be implanted in the trapezial bone of the wrist. It is made of molded silicone elastomer. The device is intended to be used in the treatment of thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint of the thumb or thumb and index finger in combination. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity.