CONTOUR LABRAL NAIL, MODEL 533520A

K003970 · Bionx Implants, Inc. · MAI · Jan 12, 2001 · Orthopedic

Device Facts

• Record ID: K003970
• Device Name: CONTOUR LABRAL NAIL, MODEL 533520A
• Applicant: Bionx Implants, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Jan 12, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Contour Labral Nail™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or reoccurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).

Device Story

Absorbable fixation fastener; used for soft tissue-to-bone reattachment in shoulder repair. Device maintains proximity between tissues to facilitate healing. Composed of poly-L,D-lactide copolymer; dimensions 20mm length, 3.5mm diameter. Implanted by surgeons during shoulder stabilization procedures to address anterior instability/Bankart lesions. Provides mechanical fixation; eliminates need for permanent hardware due to absorbable nature.

Technological Characteristics

Absorbable fastener; material: poly-L,D-lactide copolymer; dimensions: 20mm length, 3.5mm diameter; mechanical fixation principle.

Indications for Use

Indicated for internal fixation of soft tissue to bone in patients with primary or recurrent anterior shoulder instability (Bankart lesions) requiring reattachment of the glenoid labrum and/or inferior glenohumeral ligament.

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

• Bionx Bankart Tack™ (K973849)
• Anatomical Bankart Tack™ (K992567)

Submission Summary (Full Text)

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K003970

JAN 1 2 2001

# 510(k) Summary Bionx Implants Inc. Contour Labral Nail™

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

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

Contacts:

Gerard S. Carlozzi President, CEO Phone: [phone] Facsimile: [phone]

| Bionx Implants Ltd. | |
|---------------------|----------------|
| Tuija Annala | |
| Quality Manager | |
| P.O.Box 3 | |
| FIN-33721 Tampere | |
| Finland | |
| Phone: | 358-3-316 5679 |
| Facsimile: | 358-3-316 5688 |

Date prepared:

December 14th, 2000

Name of the device:

Trade or Proprietary Name: Contour Labral Nail™ A.

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| B. | Common Name: |
|----|----------------------|
| C. | Classification Name: |

Bionx Contour Labral Nail Biodegradable soft tissue fixation fasteners

- D. Device Product Code: 87 MAI
## Predicate Device:

Bionx Implants Inc. Bankart Tack™ Biodegradable soft tissue fixation fastener (K973849) and Anatomical Bankart Tack™ (the current Contour Labral Nail™) Biodegradable soft tissue fixation fastener (K992567).

#### Intended Use:

The Contour Labral Nail™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or reoccurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).

#### Device Description:

The Contour Labral Nail™ is an absorbable device designed to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Contour Labral Nail™ is composed of poly-L,Dlactide copolymer, its length is 20mm and diameter 3.5mm.

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## Substantial Equivalence:

The Contour Labral Nail™ is substantially equivalent to the cleared Bionx Bankart Tack™ (K973849) and Anatomical Bankart Tack™ (the current Contour Labral Nail™) (K992567). All three devices have the same intended use, similar principles of operation and technological characteristics. Furthermore, the minor technological differences between the Contour Labral Nail™ and the predicate devices do not raise any new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines beneath them.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2001

Bionx Implants, Inc. Ms. Tuija Annala Quality Manager c/o Bionx Implants, LTD Hermiankatu 6-8 L Tampere, Finland

Re: K003970

Trade Name: Contour Labral Nail™ Regulatory Class: II Product Code: MAI, MNN and MRY Dated: December 19, 2000 Received: December 22, 2000

Dear Ms. Annala:

We have reviewed your Section 510(k) 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 been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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## Page 2 - Ms. Tuija Annala

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

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# INDICATIONS FOR USE

**510(K) Number (if known):** K003970

Device Name:

Contour Labral Nail™

### Indications for Use:

The Bionx Contour Labral Nail™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Contour Labral Nail™ will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligaments in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e. Bankart lesions).

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

Prescription Use ﮐﮯ (Per 21 CFR 801.109)

Over-The-Counter Use_ OR

Muriam C. Provost

of General Restorative Devices 510(k) Number_ K003970