UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)

K961051 · Kinetikos Medical, Inc. · JWJ · Jun 6, 1996 · Orthopedic

Device Facts

• Record ID: K961051
• Device Name: UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)
• Applicant: Kinetikos Medical, Inc.
• Product Code: JWJ · Orthopedic
• Decision Date: Jun 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KMI Universal Total Wrist™ System is indicated for intractable pain resulting from traumatic arthritis, osteo arthritis, rheumatoid arthritis, trauma induced osteo arthritis of the radial / Carpal joint. To replace functionality of the joint due to deformity or elements stated above.

Device Story

Universal Total Wrist™ System is a semi-constrained wrist prosthesis designed to replace the radial/carpal joint. System consists of carpal plate implants (titanium alloy), radial implants (CrCoMo), and poly bearing implants. Available in three sizes (small, medium, large). Intended for use with bone cement. Implanted by orthopedic surgeons in a clinical/surgical setting to relieve pain and restore joint functionality. Device replaces weakened bone anatomy. Clinical benefit derived from over 20 years of established clinical evaluation of similar wrist replacement designs.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the long-term clinical history and well-documented performance of similar wrist implant systems over 20 years.

Technological Characteristics

Semi-constrained wrist prosthesis. Materials: Titanium alloy 6AL-4V ELI (ASTM F136-84) for carpal plate; CrCoMo (ASTM F-75-87) for radial implant. Instrumentation: Stainless steel (ASTM F899-84). Sterilization: Gamma radiation (25-45 Kgy) to SAL 10^-6 per AAMI guidelines.

Indications for Use

Indicated for patients with intractable pain or joint deformity resulting from traumatic arthritis, osteoarthritis, or rheumatoid arthritis of the radial/carpal joint.

Regulatory Classification

Identification

A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Protek Meuli Wrist
• Howmedica AMC Wrist
• Depuy Bi-Axial Wrist

Submission Summary (Full Text)

{0}

6-04-1996 10:19AM FROM KMI ' 619 558 0838 JUN - 6 1996 K961051
Confidential

FDA Notification of:
Summary of Safety and Effectiveness Information
Product: Universal Total Wrist™ System

## Summary of Safety and Effectiveness Information

For Release Upon Request Only

### Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

### Company Name / Contact:

**Company:** KMI (Kinetikos Medical Inc.)
3950 Sorrento Valley Blvd
San Diego, Ca 92120

**Contact:** Regulatory Affairs Department
KMI
3950 Sorrento Valley Blvd
San Diego, Ca 92110
[phone]

**Establishment Registration Number:** 2028840

**Classification Name:** Wrist Prosthesis (metal/plastic/metal semi-constrained), 87JWJ

**Common Used Name:** Wrist Prosthesis

**Trade Proprietary Name:** Universal Total Wrist™ System

The FDA has classified similar products as a Class II device by the Orthopedic Device Section of the Surgical and Rehabilitation Devices Panel at Section 888-304. The product code generally refereed to is 87JWJ (Product Code: JWJ), and KMI submits this application under this designation.

3950 SORRENTO VALLEY BLVD., SAN DIEGO, CALIFORNIA 92121 TELEPHONE: [phone] FACSIMILE: [phone]

{1}

6-04-1996 10:19AM FROM KMI 1 619 558 0838
P. 3
KINETIKOS MEDICAL
KMI
INCORPORATED
Confidential

FDA Notification of:
Summary of Safety and Effectiveness Information
Product: Universal Total Wrist™ System

## Performance Standards:

No performance standards applicable to semi-constrained wrist implant have been established by the FDA. However, the titanium alloy 6AL-4V ELI alloy used to manufacture the carpal plate implant meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84). Additionally, the CrCoMo used in the radial implant per ASTM F-75-87 meets the chemical and mechanical requirements of the voluntary standards established by the American Society for Testing and Materials (ASTM 136-84, B 800-74).

## Package and Labeling:

Draft Package labeling has been developed and enclosed in Section 2 attachments. A draft package insert has also been developed and enclosed in Section 2 for your review and consideration.

## System Description:

The KMI will be offered in three sizes (small, medium, and large) with the poly bearing implant also offered in three sizes to match the carpal plate implants. The Universal total Wrist implant is constructed of materials that have a long clinical history of proven acceptance and performance. This system is intended for use with cement and will be promoted as such in the UTW surgical protocol

## Indications for Use:

The KMI Universal Total Wrist™ System is indicated for intractable pain resulting from traumatic arthritis, osteo arthritis, rheumatoid arthritis, trauma induced osteo arthritis of the radial / Carpal joint. To replace functionality of the joint due to deformity or elements stated above.

## Substantial Equivalent Devices:

This product is substantially equivalent in design, composition and/or function to other orthopedic implant devices manufactured and approved for market.

Protek Meuli Wrist: K?
Howmedica AMC Wrist: K?
Depuy Bi-Axial Wrist: K?

3950 SORRENTO VALLEY BLVD., SAN DIEGO, CALIFORNIA 92121 TELEPHONE: [phone] FACSIMILE: [phone]

{2}

6-04-1996 10:19AM FROM KMI 1 619 558 0838
P. 4
KINETIKOS MEDICAL
KMI
INCORPORATED
Confidential

FDA Notification of:
Summary of Safety and Effectiveness Information
Product: Universal Total Wrist™ System

## Instrumentation:

KMI Universal Total Wrist™ system instrumentation used for the preparation and insertion of the UTW implants is considered to be general orthopaedic instrumentation. The system includes standard manual orthopaedic surgical instruments of the appropriate size and type. All Universal Total Wrist System instruments are manufactured from stainless steel meeting ASTM F899-84 standards.

## Product Sterilization:

KMI will supply all implants Sterile. The product will be sterilized by Gamma radiation. The minimum dosage will be 25Kgy with a maximum of 45Kgy. Validation of the product will be made to ensure a sterile assurance level (SAL) of 10-6 per AMMI standard guidelines.

## Summary:

Substantial Equivalence for the KMI Universal Total Wrist™ system may be found in comparison with devices from a number of manufactures. Wrist implant systems in general have been used for many years, and the clinical performance is well known and documented in the body of this submission.

Another measure of the Safety and Effectiveness of a medical device is how it performs in long term use. The basic design concept of replacing the weakened bone anatomy of the wrist for relief from traumatic arthritis, osteo arthritis, and rheumatoid arthritis has over 20 years of clinical evaluation. Uses, Indications, limitations and surgical techniques are well understood. Standardized manufacturing methods, design practices, material selections and testing techniques are known and represented within the guidelines of this submittal.

3950 SORRENTO VALLEY BLVD., SAN DIEGO, CALIFORNIA 92121 TELEPHONE: [phone] FACSIMILE: [phone]