ARTELON SPACER CMC-1

K040070 · Artimplant AB · KYI · Sep 21, 2004 · Orthopedic

Device Facts

• Record ID: K040070
• Device Name: ARTELON SPACER CMC-1
• Applicant: Artimplant AB
• Product Code: KYI · Orthopedic
• Decision Date: Sep 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Artimplant Artelon® Spacer CMC-I The Artelon™ Spacer CMC-I is intended to be implanted into the first carpometacarpal joint as an interpositional spacer between the trapezium and first metacarpal. The device is intended to be used in thumb disabilities because of osteoarthritis.

Device Story

Artelon™ Spacer CMC-I is a one-piece interpositional spacer implanted into the first carpometacarpal (CMC-I) joint. It functions as a mechanical spacer between the trapezium and first metacarpal bone to address thumb disabilities caused by osteoarthritis. The device is intended for surgical implantation by a physician. It provides a physical barrier to improve joint function and alleviate symptoms associated with osteoarthritis. The device is supplied sterile.

Clinical Evidence

Clinical evaluation was conducted in accordance with ISO 13485 and 21 CFR Part 820. Specific study results, sample sizes, or statistical metrics were not provided in the summary document.

Technological Characteristics

One-piece interpositional spacer. Material: Artelon™, a polycaprolactone-based poly(urethane urea) in multifilament form. Sterile. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients with thumb disabilities due to osteoarthritis requiring interpositional spacing between the trapezium and first metacarpal bones.

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

• Avanta Orthopedics TRL Trapezium Soft Skeletal Implant (K964381)

Submission Summary (Full Text)

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### 510(K) SUMMARY

## SEP 2 1 2004

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In accordance with 21 CFR 807.92, the following information constitutes the Artimplant AB's summary for the Artelon™ Spacer CMC-I

| SUBMITTER'S NAME: | Artimplant AB |
|---------------------|--------------------------------------------------------------|
| ADDRESS: | Hulda Mellgrens gata 5, SE-421 32 Västra Frölunda,<br>Sweden |
| CONTACT PERSON: | Britt Novén |
| TELEPHONE NUMBER: | [phone] or [phone] |
| FAX NUMBER: | [phone] |
| DATE OF SUBMISSION: | January 5, 2004 |

#### 1. Identification of device

Proprietary Name: Artelon™ Spacer CMC-I Common Name: Prosthesis, wrist, carpal trapezium Classification Status: Class II per regulations §888.3770 Product Codes: KYI - Wrist joint carpal trapezium polymer prosthesis

#### 2. Equivalent devices

The Artimplant Artelon™ Spacer CMC-I is substantially equivalent to the Avanta Orthopedics TRL Trapezium Soft Skeletal Implant (K964381)

#### 3. Description of the Device

The Artelon™ Spacer CMC-I is a one-piece device intended to be implanted into the CMC-I joint and serve as an interpositional spacer between the trapezium bone and the first metacarpal bone.

It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form.

The Artelon™ Spacer CMC-I will be offered sterile.

#### 4. Intended use

The Artelon™ Spacer CMC-I is intended to be implanted into the CMC-I joint as an interpositional spacer between the trapezium bone and the first metacarpal bone.

The device is intended to be used in thumb disabilities because of osteoarthritis.

#### న. Predicate device

Substantial Equivalence: The Artimplant Artelon™ Spacer CMC-I is substantially equivalent to the Avanta Orthopedics TRL Trapezium Soft Skeletal Implant (K964381).

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K040070

#### 6. Discussion of performance testing

A collection of tests has been conducted and successfully completed including safety and biocompatibility studies, tensile and compression tests and clinical evaluation in accordance to Artimplant's Quality System based on ISO 13485 and 21 CFR Part 820.

#### 7. Discussion of Substantial Equivalence

Based on extensive technical and clinical performance testing and a comparison of the design and materials of the Artelon™ Spacer CMC-I to the predicate Avanta TRL Trapezium Implant, the Artelon™ Spacer CMC-I is substantially equivalent to the Avanta TRL Trapezium Implant (K964381) and presents no new concerns about safety and effectiveness. Additionally, the device has the same indications as the predicate device, and the labeling of the device is consistent with current medical practice.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

SEP 2 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Artimplant AB C/o Ms. Marie Marlow President and CEO M Squared Associates, Inc. 719 A Street. NE Washington, DC 20002

Re: K040070

Trade/Device Name: Artimplant AB, Artelon™ Spacer CMC-I Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: June 22, 2004 Received: June 23, 2004

Dear Ms. Marlow:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. o re(x) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to connineres prof to may 20, 2019, in accordance with the provisions of the Federal Food, Drug, the rices mat nave been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The rou may, morelore, mans 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 may be subject to bach additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a assist regulations administered by other Federal agencies. You must or uny I ederal battler and states and states and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF N Fart 007), accems (21 (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.

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Page 2 - Ms. Marie Marlow

This letter will allow you to begin marketing your device as described in your Section 510(k) Find lotter with and wy of substantial equivalence of your device of your device to a legally promatics notificate 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 if you attence of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Oiner general mill 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,

Sincerely yours,

Mark N. Mikkelsen

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

Enclosure

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# Indications for Use

510(k) Number (if known): K040070

Artimplant AB, Artelon™ Spacer CMC-1 Device Name:

Indications for Use:

The Artimplant Artelon® Spacer CMC-I The Artelon™ Spacer CMC-I is intended to be implanted into the first carpometacarpal joint as an interpositional spacer between the trapezium and first metacarpal.

The device is intended to be used in thumb disabilities because of osteoarthritis.

Prescription Use (Part 21 CFR 801 Subpart

AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C) Nb

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mulkerson

Division of General, Restorative, and Neurological Devices

**510(k) Number** K040070

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