WRIST IMPLANT

K021859 · Avanta Orthopaedics, Inc. · JWJ · Dec 2, 2002 · Orthopedic

Device Facts

• Record ID: K021859
• Device Name: WRIST IMPLANT
• Applicant: Avanta Orthopaedics, Inc.
• Product Code: JWJ · Orthopedic
• Decision Date: Dec 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Avanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.

Device Story

Wrist implant system for surgical replacement of painful wrist joint; semi-constrained design; includes various sizes and sizers. Fixation via intramedullary stem (proximal) and screw (distal). Used by orthopedic surgeons in clinical/surgical settings. Replaces joint functionality to alleviate pain and restore motion. Benefits patients suffering from rheumatoid, osteo-, or post-traumatic arthritis.

Clinical Evidence

Bench testing only. Fatigue and wear testing performed to demonstrate substantial equivalence to predicate device.

Technological Characteristics

Semi-constrained wrist prosthesis. Materials: Cobalt-Chromium (Co-Cr), Ultra-High Molecular Weight Polyethylene (UHMWPE), and Commercially Pure Titanium (CPTi). Fixation: Intramedullary stem and screw. Sizes: Small, medium, large (left/right).

Indications for Use

Indicated for patients requiring replacement of painful wrist joint due to rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis.

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

• Universal Total Wrist System, KMI (K961051)

Submission Summary (Full Text)

{0}------------------------------------------------

K021859 Pge \$\frac{1}{2}\$

## DEC 0 2 2002

#### 510 (k) Summary

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

| Prepared: | June 5, 2002 |
|------------|----------------------------------|
| Applicant: | Avanta Orthopaedics, Inc. |
| | 9369 Carroll Park Drive, Suite A |
| | San Diego, CA 92121 |
| Telephone: | 858-452-8580 |
| Fax: | 858-452-9945 |
| Contact: | Louise M. Focht |

| Device Name: | Wrist |
|------------------------|--------------------------------------------|
| Device Trade Name: | Wrist implant |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3800 |
| Product Code: | JWJ |
| Predicate Device: | Universal Total Wrist System, KMI, K961051 |
| Registration Number: | 2030506 |
| Owner Operator Number: | 9001389 |

Device Description:

The wrist implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the wrist.

Indications for Use:

A vanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.

Comparison to Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Universal Total Wrist System, KMI, K961051.

Table. Comparison of Avanta Orthopaedics and KMI wrist.

{1}------------------------------------------------

| page 3 of 2 | |
|----------------------------------|--|
| | |
| KMI | |
| KMI Universal Total Wrist System | |
| | |

| Item | Avanta Product | KMI |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Wrist Implant | KMI Universal Total Wrist System |
| Use | Single use | Single use |
| Fixation | stem in intramedullary canal,<br>proximally<br>Screw fixation distally | stem in intramedullary canal,<br>proximally<br>Screw fixation distally |
| Constraint | Semi-constrained | Semi-constrained |
| Material | Co-Cr/UHMWPE/CPTi | Co-Cr/UHMWPE/CPTi |
| Sizes | 3 sizes small, medium, large<br>Right, Left | 3 sizes small, medium, large<br>Right, Left |
| Indications for use | Avanta Orthopaedics Wrist implant is<br>intended for replacement of the painful<br>wrist joint due to:<br>rheumatoid arthritis, oseto-arthritis, or<br>post-traumatic arthritis. | The KMI Universal Total Wrist System<br>is indicated for:<br>Intractable pain resulting from<br>traumatic arthritis, osteo arthritis,<br>rheumatoid arthritis, trauma induced<br>osteo arthritis of the radial/Carpal joint.<br>To replace functionality of the joint due<br>to deformity of elements stated above. |

Similarities of the Avanta Orthopaedics wrist implant and the KMI Universal Total Wrist System include;

Both devices are intended for single use only;

Both devices are intended for surgical implantation longer than 30 days;

Both devices are placed into the wrist joint;

Both devices are made of industry standard materials. No new materials are introduced in either product;

Both devices are comparably sized;

Both devices have the same indications for use.

Fatigue and wear testing have been performed on this devices to demonstrate substantial equivalence.

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 02 2002

Mr. H. Doug Plunkett General Manager Avanta Orthopaedics 8600 Evergreen Boulevard Minneapolis, Minnesota 55433

Re: K021859

Trade/Device Name: Wrist Implant Regulation Number: 21 CFR 888.3800 Regulation Name: Wrist Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWJ Dated: August 31, 2002 Received: September 5, 2002

Dear Mr. Plunkett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 – Mr. H. Doug Plunkett

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

10 (k) Number (If Kno Device Name: Wrist

Comments of the country

### Indications for Use:

Avanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.

(Division Sign-Off)

510(k) Number K021859

# (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

h is Prescription Use _ (Per 21 CFR § 801.109) OR

Over-the-Counter Use _ No (Optional Format 1-2-96)

isiam C. Provost

ு Olvision Sign-Off) Division of Genera and Neurological L. . vices

K021859