NUGEN FX SCREW

K023022 · Bionx Implants, Inc. · HWC · Oct 4, 2002 · Orthopedic

Device Facts

• Record ID: K023022
• Device Name: NUGEN FX SCREW
• Applicant: Bionx Implants, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NuGen™ FX Screw is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus. The NuGen™ FX Screw is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

Device Story

Bioabsorbable, threaded fixation rod; composed of poly-L,D-lactide copolymer. Used for bone fixation/alignment in upper extremity, ankle, and foot. Implanted by surgeons during orthopedic procedures. Provides mechanical stabilization of fractures/osteotomies; degrades over time. Supplied in 3.5mm and 4.5mm diameters; lengths 14-70mm. No electronic or software components.

Clinical Evidence

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

Technological Characteristics

Poly-L,D-lactide copolymer; bioabsorbable threaded fixation rod. Diameters: 3.5mm (14-40mm length) and 4.5mm (24-70mm length). Mechanical fixation principle. Sterilized using established processes.

Indications for Use

Indicated for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses, or condylar grafts in upper extremity, ankle, and foot condylar aspects. Specific applications: phalangeal, metacarpal, carpal, wrist, distal radius, olecranon, radial head, humeral condylar, malleolus, ankle, metatarsal, and hallux valgus correction. Contraindicated for cortical bone fractures (except hand/foot), proximal femoral fractures, active/potential infection, and patients lacking cooperation (e.g., alcoholism).

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

• Biofix® Bioabsorbable SR-PLLA Threaded Fixation Rod (K952471)
• Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876)
• Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K992947)
• SmartScrew™ (K003077)
• SmartScrew™ (K012001)

Submission Summary (Full Text)

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OCT 0 4 2002

# 510(k) Summary Bionx Implants Inc. NuGen™ FX Screw

K023022
page 1 of 2

### 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

Date prepared: December 19, 2001

#### Name of the device:

| A. | Trade or Proprietary Name: | NuGen™ FX Screw |
|----|----------------------------|---------------------------------------|
| B. | Common Name: | Bioabsorbable, Threaded, Fixation Rod |
| C. | Classification Name: | Biodegradable fixation fastener, bone |
| D. | Device Product Code: | HWC |

#### Predicate Devices:

Bionx Implants Inc. Biofix® Bioabsorbable SR-PLLA Threaded Fixation Rod (K952471) Bionx Implants Inc. Biofix® Bioabsorbable, Threaded, Distal Radius Screw (K974876, K992947) Bionx Implants Inc. SmartScrew™ (K003077) Bionx Implants Inc. SmartScrew™ (K012001)

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## Intended Use:

KC2 3022
page 2 of 2

NuGen™ FX Screw is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or Specifically, it is intended for phalangeal fusion and fracture, immobilization. metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

The NuGen™ FX Screw is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

#### Device Description:

NuGen™ FX Screw is composed of poly-L,D-lactide copolymer. It is supplied partly threaded with 3.5mm in diameter, lengths 14-40mm and 4.5mm in diameter, lengths 24 - 70mm.

#### Substantial Equivalence:

NuGen™ FX Screw has the following similarities to the cleared SmartScrew (K003077):

- has the same indicated use -
- uses the same operating principle
- incorporates the same basic design of thread
- utilizes the same basic dimensions -
- is packaged and sterilized using the same materials and processes
- has the same shelf life

This raw material and design of head of screw are already introduced with fully threaded screw model (K012001).

The predicate device is the Bionx Implants Inc. SmartScrew™ (K952471, K974876, K992947, K003077, K012001). These devices have very similar principles of operation and technological characteristics.

In summary, the NuGen™ FX Screw described in this notification is, in our opinion, substantially equivalent to the predicate devices. Furthermore, the minor technological differences between the NuGen™ FX Screw and the predicate devices do not raise any new issues of safety or effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 0 4 2002

Mr. Gerard S. Carlozzi President and Chief Executive Officer Bionx Implant. Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Blue Bell, Pennsylvania 19422

Re: K023022

Trade Name: NuGen™ FX Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 16, 2002 Received: September 11, 2002

Dear Mr. Carlozzi:

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 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 (OS) 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 - Mr. Gerard S. Carlozzi

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): K023022

Device Name:

NuGen™ FX Screw

#### Indications for Use:

The NuGen™ FX Screw is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

The NuGen™ FX Screw is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

Please do not write below this line - continue on another page is needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over-The-Counter Use

(Per 21 CFR 801.109)

L. Mark N. Milliken

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

510(k) number K023022