SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525

K993074 · Bionx Implants, Ltd. · MAI · Dec 10, 1999 · Orthopedic

Device Facts

• Record ID: K993074
• Device Name: SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525
• Applicant: Bionx Implants, Ltd.
• Product Code: MAI · Orthopedic
• Decision Date: Dec 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Properly used, in the presence of adequate immobilization, absorbable SmartNail™ 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. The SmartNail™ includes an arthroscopic applicator set. The arthroscopic applicator set consists of Handle, Tip, Piston, House, Wrench, Drill bit and K-wires. The SmartNail™ 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 SmartNail™ upon the healing of growth plate has not been tested clinically.

Device Story

Absorbable bone fixation nail; used for non-load bearing bone fragments, osteotomies, and arthrodeses. Device features 1.5 mm diameter, 16-25 mm lengths, and 5 barbs on two sides to prevent migration. Implanted via arthroscopic applicator set (handle, tip, piston, house, wrench, drill bit, K-wires). Operates as mechanical fixation device; provides temporary stabilization during bone healing. Material: polylactide homopolymer and copolymer; strength retention 20-50 weeks. Used by surgeons in clinical/OR settings. Benefits patient by providing internal fixation that resorbs, potentially eliminating need for secondary removal surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Absorbable bone fixation nail; material: polylactide homopolymer and copolymer; strength retention 20-50 weeks. Dimensions: 1.5 mm diameter, 16-25 mm lengths. Features 5 barbs for fixation. Includes mechanical arthroscopic applicator set.

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 fractures (except hand/foot), weight-bearing cancellous bone, patients with active/potential infection, patients with poor cooperation (e.g., alcoholism), and pediatric physeal fractures.

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 Implants, Inc. Biofix® SR-PGA Pin (K890902)
• Bionx Implants Inc. SmartPin™ (K925098)
• Johnson & Johnson Orthopedics, Inc. Orthosorb Absorbable Pin (K864912, K882979, K901456)
• Synthes Inc. Polypin (K961608)

Submission Summary (Full Text)

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K993074

# 510(k) Summary Bionx Implants Inc. SmartNail™

#### 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 and COO [phone] Phone: Facsimile: [phone]

> Bionx Implants Ltd. Tuija Annala Regulatory Affairs Assistant P.O.Box 3 FIN-33721 Tampere Finland Phone: [phone] Facsimile: 358-3-316 5688

#### September 2nd, 1999 Date prepared:

### Name of the device:

- SmartNail™ A. Trade or Proprietary Name: B.
- Absorbable Bone Fixation Nail Common Name:
- ﺰﺓ Classification Name: Bone Fixation Nail
- D. Device Product Code: IDS

## Predicate Devices:

- 1. Bionx Implants, Inc. Biofix® SR-PGA Pin (K890902)
- Bionx Implants Inc. SmartPin™ (K925098) 2.
- Johnson & Johnson Orthopedics, Inc. Orthosorb Absorbable Pin (K864912, 3. K882979, K901456)
- 4. Synthes Inc. Polypin (K961608)

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# Intended Use:

Properly used, in the presence of adequate immobilization, absorbable SmartNail™ 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. The SmartNail™ includes an arthroscopic applicator set. The arthroscopic applicator set consists of Handle, Tip, Piston, House, Wrench, Drill bit and K-wires.

The SmartNail™ 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 SmartNail™ upon the healing of growth plate has not been tested clinically.

# Device Description:

The SmartNail™ is provided with a diameter of 1.5 mm and lengths of 16, 20 and 25 mm. 5 barbs, placed at intervals of 1.5 mm on two sides of the SmartNail™, prevent the implanted SmartNail™ from slipping out. The SmartNail™ is made of polylactide homopolymer and polylactide copolymer materials with strength retention time 20-50 weeks.

### Substantial Equivalence:

Bionx Implants Inc. SmartNail™ is substantially equivalent to the cleared Bionx Implants Inc. Biofix® SR-PGA Pin (K890902) and SmartPin™ (K925098), Johnson & Johnson Orthopedics, Inc. Orthosorb Absorbable Pin (K864912, K882979, K901456) and Synthes Inc. Polypin (K961608). The SmartNail™, Biofix® SR-PGA Pin (K890902), Orthosorb® (K864912, K882979, K901456) and Synthes Polypin (K961608) have the same intended use and principles of operation and very similar technological characteristics.

Furthermore, the minor technological differences between the Bionx Implants Inc. SmartNail™ and the predicate devices 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 & Human Services. The logo features a stylized eagle with three stripes forming its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 0 1999

Mrs. Tuija Annala Regulatory Affairs Assistant Bionx Implants Ltd. P.O. Box 3 FIN-33721 Tampere Finland

Re: K993074

Trade Name: SmartNail Regulatory Class: II Product Code: MAI Dated: September 3, 1999 Received: September 14, 1999

Dear Mrs. 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 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 (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.

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Page 2 - Mrs. Tuija Annala

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.

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, please 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.

Neil R.P. Ogden

James E. Dillard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

510(K) Number (if known): K993074

Device Name:

SmartNail™

#### Indications for Use:

The SmartNail™ 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.

The SmartNail™ 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 SmartNail™ 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

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR

(Per 21 CFR 801.109)

Russell / Vaison sur T20

Division of General Restorativ 10(k) Number __