MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214

K013546 · Bionx Implants, Inc. · HWC · Nov 21, 2001 · Orthopedic

Device Facts

• Record ID: K013546
• Device Name: MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
• Applicant: Bionx Implants, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 21, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Properly used, in the presence of adequate immobilization, 1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments. 1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of the implant upon the healing of growth plate has not been tested clinically.

Device Story

Absorbable bone fixation nail; used for stabilizing non-load bearing bone fragments, osteotomies, and arthrodeses. Composed of poly-L/D-lactide copolymer; 1.5mm diameter; available in lengths 14-25mm. Implanted by surgeons in clinical settings to provide internal fixation. Device provides mechanical stabilization of bone fragments during healing. Modification adds 14mm length to existing product line. Sterile, single-use, disposable.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: poly-L/D-lactide copolymer. Form factor: 1.5mm diameter nail, lengths 14-25mm. Sterile, single-use, disposable. Packaging: blister pack with Tyvek lid inside aluminum foil pouch.

Indications for Use

Indicated for fixation of non-load bearing bone fragments, osteotomies, and arthrodeses (e.g., apical, osteochondral, cancellous fragments). Contraindicated for cortical bone (except foot/hand), weight-bearing cancellous bone, active infection, patients with poor cooperation (e.g., alcoholism), and pediatric physeal fractures.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• SmartNail (K993074)
• 1.5mm Bone Fixation Kit (K012000)

Submission Summary (Full Text)

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# 510(k) Summary NOV 21 2001 Bionx Implants Inc. 1.5mm Bone Fixation Kit

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

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

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

> Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland, Europe 358-3-316 5600 Phone: [phone] Facsimile:

October 9th, 2001 Date prepared:

#### Name of the device:

| A. | Trade or Proprietary Name: 1.5mm Bone Fixation Kit | |
|----|----------------------------------------------------|-------------------------------|
| B. | Common Name: | Absorbable Bone Fixation Nail |
| C. | Classification Name: | Bone Fixation Nail |
| D. | Device Product Code: | MAI and HWC |

#### Predicate Device:

- 1. Bionx Implants, Inc. SmartNail (K993074)
- 2. Bionx Implants, Inc. 1.5mm Bone Fixation Kit (K012000)

#### Intended Use:

Properly used, in the presence of adequate immobilization, 1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

ﺴﺴ

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1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of the implant upon the healing of growth plate has not been tested clinically.

# Device Description:

The device description of the 1.5mm Bone Fixation Kit is as follows.

- The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000)
- Lengths of implants are 14, 16, 18, 20 and 25 mm. -
- Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) and -1.5mm Bone Fixation Kit (K012000)
- Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000). -
- Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.

The modifications are:

- Amendment of new length, 14mm implant, into product line. -
- Modified design accordingly. -

### Substantial Equivalence:

Bionx Implants Inc. 1.5mm Bone Fixation Kit is substantially equivalent to the cleared Bionx Implants Inc. SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000). This amendment of one new length with little change in design does not raise any new concerns of safety and efficacy of the implant. This modification has no effect on pull-out properties of the device.

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Image /page/2/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" arranged around the perimeter. In the center of the seal is a stylized image of three birds in flight, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2001

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

Re: K013546

Trade/Device Name: 1.5mm Bone Fixation Kit Regulation Number: 21 CFR §888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC and MAI Dated: October 8, 2001 Received: October 24, 2001

Dear Mrs. Annala:

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 for abouted in the 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.

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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 A. Millenson

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): KO13546

NOV 21 2001

#### 1.5mm Bone Fixation Kit Device Name:

## Indications for Use:

1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of 1.5mm Bone Fixation Kit upon the healing of growth plate has not been tested clinically.

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

Prescription Use V

(Per 21 CFR 801.109)

OR Over-The-Counter Use