CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116

K012334 · Bionx Implants, Inc. · MAI · Sep 19, 2001 · Orthopedic

Device Facts

• Record ID: K012334
• Device Name: CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
• Applicant: Bionx Implants, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Sep 19, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

Device Story

Contour Meniscus Arrow is a bioabsorbable fastener for arthroscopic fixation of longitudinal vertical meniscus lesions. Device consists of poly-L/D-polylactide copolymer; available in 10, 13, and 16mm lengths with 1.1mm diameter. Used by surgeons during arthroscopic procedures to stabilize meniscus tears in vascular zones. Operates as a mechanical fixation device to hold tissue in place during healing. Benefits patient by providing secure fixation for meniscus repair, facilitating healing while immobilized.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological similarities to predicate devices.

Technological Characteristics

Material: poly-L/D-polylactide copolymer. Form factor: fastener, 1.1mm diameter, 10-16mm lengths. Principle: mechanical soft tissue fixation. Sterilization: same as predicate.

Indications for Use

Indicated for patients requiring arthroscopic fixation of longitudinal vertical (bucket-handle) meniscus lesions in the vascular (red-red or red-white) zones, used with immobilization.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Biofix® Biodegradable Meniscus Arrow System (K955768)
• Meniscus Arrow (K993453)

Submission Summary (Full Text)

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K012334

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## 510(k) Summary Bionx Implants Inc. Meniscus Arrow™

Submitter's Name, Address, Telephone Number, and Contact Person

Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Blue Bell, PA 19422

Contacts:

Gerard S. Carlozzi President and Chief Executive Officer [phone] Phone: Facsimile: [phone]

Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland Phone: [phone] Facsimile: 358-3-316 5629

July 9th, 2001 Date prepared:

#### Name of the device:

| A. | Trade or Proprietary Name: | Contour Meniscus Arrow™ |
|----|----------------------------|---------------------------------------------|
| B. | Common Name: | Bioabsorbable Meniscus Arrow System |
| C. | Classification Name: | Biodegradable soft tissue fixation fastener |
| D. | Device Product Code: | MAI |

#### Predicate Devices:

Bionx Implants Inc. Biofix® Biodegradable Meniscus Arrow System (K955768) Bionx Implants Inc. Meniscus ArrowTM (K993453)

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#### Intended Use:

The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

The principles of operation is completely identical with the predicate device.

#### Device Description:

The device description of the Contour Meniscus Arrow™ is as follows.

- Composed of poly-L/D-polylactide copolymer ।
- Length 10, 13 and 16mm -
- । Diameter 1.1mm

The dimensions and shape subtstantially equivalent to the Biofix® Biodegradable Meniscus Arrow System (K955768) and Meniscus Arrow (K993453).

#### Substantial Equivalence:

The Contour Meniscus Arrow™ has the following similarities to the cleared Biofix® Biodegradable Meniscus Arrow System (K955768) and Meniscus Arrow (K993453):

- has the same indicated use
- uses the same operating principle -
- incorporates the same basic design
- is manufactured by same machinery -
- is packaged and sterilized using the same materials and processes -
- has the same shelf life

In summary, the Contour Meniscus Arrow™ described is substantially equivalent to the predicate device. This change of raw material and minor modifications of the design does not raise any new problems concerning safety or efficacy of the device.

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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 to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2001

Bionx Implants, Inc. c/o Ms. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants. Ltd. Hermiankatu 6-8 L Tampere, Finland

Re: K012334/S001

Trade Name: Contour Meniscus Arrow Regulation Number: Unclassified Regulation Name: Fastener, fixation, biodegradable, soft tissue Regulatory Class: Unclassified Product Code: MAI Dated: August 28, 2001 Received: August 30, 2001

Dear Mrs. Annala:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have May 20, 1970, the charenean and 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, oond 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 If your device 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 r hat 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 or unry 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 OFF Part 8077, laboring (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. Tuija Annala

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.

Susan Walker, us

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

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### INDICATIONS FOR USE

# 510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Contour Meniscus Arrow™M

Indications for Use:

The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use*_*_\r
✓

(Per 21 CFR 801.109)

Over-The-Counter Use_ OR

SL

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012334