BIOCUFF,C, MODELS 236018, 236028, 236036

K013057 · Bionx Implants, Inc. · MAI · Oct 12, 2001 · Orthopedic

Device Facts

• Record ID: K013057
• Device Name: BIOCUFF,C, MODELS 236018, 236028, 236036
• Applicant: Bionx Implants, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Oct 12, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Properly used, in the presence of adequate immobilization, absorbable BioCuff CM screw/washer maintains proximity between soft tissue and bone to facilitate the soft tissue reattachment. BioCuff C™ loses its strength over 20 to 50 weeks while the lesion of the tendon is healing.

Device Story

BioCuff CTM is a bioabsorbable soft tissue fixation fastener (screw and washer) used by surgeons to maintain proximity between soft tissue and bone during tendon healing. Device is implanted during surgical procedures; provides mechanical fixation while tissue heals; loses strength over 20-50 weeks as it absorbs. Modifications from predicate include cannulated design for 1.5mm K-wire installation, increased outer diameter, and revised head geometry. Instrument set includes cannulated screwdriver, drill, grasper, and bone tap. Benefits include facilitated soft tissue reattachment and reduced need for secondary removal due to bioabsorbable material.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: poly-L/D-lactide copolymer. Form factor: cannulated screw and washer (6.0mm diameter; 18, 28, 36mm lengths). Fixation: mechanical, cannulated for 1.5mm K-wire. Sterilization: not specified. Software: none.

Indications for Use

Indicated for soft tissue reattachment to bone in patients requiring immobilization. Contraindicated in patients with insufficient bone quality/quantity, foreign body sensitivity to implant material, active sepsis or infection, or conditions limiting patient ability/willingness to restrict activities during healing.

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

• BioCuff™ (K001378)

Reference Devices

• Cannulated SmartScrew (K974876)
• Cannulated SmartScrew (K992947)

Submission Summary (Full Text)

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K013057
10FD

# 510(k) Summary Bionx Implants Inc. BioCuff CTM

Submitter's Name, Address, Telephone Number, and Contact I'crson

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] [phone] Facsimile:

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

Date prepared: August 30, 2001

## Name of the device:

- Trade or Proprietary Name: BioCuff CTM A. B. Common Name: Bioabsorbable soft tissue fixation fastencr C. Classification Name: Bioabsorbable soft tissue fixation fastener D. Device Product Code: MAJ
## Predicate Device:

Bionx Implants Inc. BioCuff™ (K001378)

#### Intended Use:

Properly used, in the presence of adequate immobilization, absorbable BioCuff CM screw/washer maintains proximity between soft tissue and bone to facilitate the soft tissue reattachment. BioCuff C™ loses its strength over 20 to 50 weeks while the lesion of the tendon is healing. This indication is completely identical with the previously cleared BioCuffM (K001378).

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K013057
20F2

Also, like the predicate devices, the BioCuff C™ is not intended for use in and is contraindicated for:

- Surgical procedures other than those listed. 】.
- Conditions that may compromise fixation with BioCuff CTM (osteopenic, 2. comminuted bone, etc.).
- Conditions that may retard healing (poor blood supply, past or potential ਲ, infection, elc.).
- Active infection. 4.
- Conditions that may limit the patient's ability or willingness to restrict న్. activities or follow directions during the healing period.
- Foreign body sensitivity to materials. 6.

## Device Description:

BioCuff CTM is composed of poly-L/D-lactide copolymer. This raw material is completely identical with the previously cleared Bionx Implants Inc. BioCuff™ (K001378).

The device description of BioCuff C™ screw and washer combination is as follows:

- Composed of poly-L/D-lactide copolymer -
- -Lengths 18, 28 and 36mm.
- Diameter 6.0 mm -
- -Cannulation for 1.5mm K-wire

The only modifications that were made are:

- Cannulated design for easier installation of the product u
- Increased outer diameter -
- Minor design changes in head of the screw and washer accordingly -
- Revision of instrument set according to needs of cannulation. This means cannulated screwdriver, cannulated drill, grasper, cannulated bone tap, sterilization tray and K-wire. Instrument set is substantially equivalent to previously cleared Bionx Implants Inc. BioCuff™ screw/washer (K001378) and Cannulated SmartScrew (K974876, K992947).
- Introduction of new reference numbers -
- Introduction of new trade name, BioCuff CTM -

## Substantial Equivalence:

The minor technological differences between BioCuff CTM and the predicate device do not raise any new issues of safety or effectiveness.

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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 features the department's name around the perimeter. In the center is a stylized emblem consisting of three curved shapes, resembling a bird or abstract design. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2001

Mrs. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants Ltd. Hermiankatu 6-8 L Tampere Finland

Re: K013057

Trade Name: BioCuff CTM Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MAI, HWC Dated: September 6, 2001 Received: September 6, 2001

Dear Mrs. Tuija Annala:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) proxime is substantially equivalent (dor in indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manetical povice Amendments, or to commence prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reciasined in asses approval of a premarket approval application (PMA). allo Cosmetic Act (71ct) that ao nov requestly of the general controls provisions of the Act. The I ou may, increrore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 is classified (600 as voyols. Existing major regulations affecting your device can thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may ou louica in the overnments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advisou that I Dr brains that your device complies with other requirements of the Act that I Dri has made a aver mixalations administered by other Federal agencies. You must or any I carated and the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the rece or of an entry (1) ; good manufacturing practice requirements as set CFR Part 6077; adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mrs. 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,

Sincerely yours,

Mark McMillan

Celia M. Witten, Ph.D., 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): K013057

Device Name:

BioCuff Circ

#### Indications for Use:

Properly used, in the presence of adequate immobilization, absorbable BioCull CM screw/washer maintains proximily between soft tissue and bone to facilitate the soft tissue reattachment. The BioCuff C™ Ioses its strength over 20 to 50 weeks while the Icsion of the tendon is healing.

The BioCuff C™ is not intended for use in and is contraindicated for: 1) Insufficient quality or quantity of bone, 2) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity. 3) Patients with active sepsis or infection. 4) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period.

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

Prescription Use

(Per 21 CFR 801.109)

OR Over-The-Counter Use_

for Mark N Milkman

10(k) Number K013057