CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED

K032447 · Linvatec Biomaterials, Ltd. · HWC · Apr 16, 2004 · Orthopedic

Device Facts

• Record ID: K032447
• Device Name: CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED
• Applicant: Linvatec Biomaterials, Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: Apr 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cannulated 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.

Device Story

Cannulated NuGen™ FX Screw is a bioabsorbable, threaded bone fixation fastener. Device is composed of poly-L/D-lactide copolymer. It features cannulation to accommodate K-wires (1.2mm or 1.6mm) for precise placement during orthopedic surgery. Available in lengths of 14-70mm and diameters of 3.5mm or 4.5mm, with fully or partly threaded configurations. Used by surgeons in clinical settings to maintain alignment of fractures, osteotomies, or arthrodeses in the upper extremity, ankle, and foot. Device provides mechanical stabilization during bone healing; it is intended to be used alongside external bracing or immobilization. The cannulated design allows for guided insertion over a K-wire, facilitating accurate positioning in cancellous bone. Benefit to patient includes internal fixation without the need for permanent metallic hardware, as the material is bioabsorbable.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Poly-L/D-lactide copolymer. Form factor: Cannulated threaded screw. Dimensions: 14-70mm length; 3.5mm (1.2mm cannulation) or 4.5mm (1.6mm cannulation) diameter. Manufacturing: Machining. Sterilization: Same as predicate. Energy source: None (mechanical).

Indications for Use

Indicated for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses, or condylar grafts in the upper extremity, ankle, and foot. Contraindicated for cortical bone fractures (except hand/foot), proximal femoral fractures, cases with active/potential infection, patients with poor cooperation (e.g., alcoholism), highly comminuted fractures, and patients with known implant material allergy.

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)
• NuGen™ FX Screw (K023022)

Submission Summary (Full Text)

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K033447
page 1 of 2

# 510(k) Summary Linvatec Biomaterials Cannulated NuGen™ FX Screw

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

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

July 29, 2003 Date prepared:

# Name of the device:

| A. | | Trade or Proprietary Name: | Cannulated 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. SmartScrewTM (K012001) Bionx Implants Inc. NuGen™ FX Screw (K023022)

# Intended Use:

Cannulated 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.

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K03>447
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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). 3) Highly comminuted fractures, which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.

### Device Description:

The device description of the Cannulated NuGen™ FX Screw biodegradable bone fixation screw is as follows.

- Composed of poly-L/D-lactide copolymer ।
- Lengths 14 70mm -
- Diameters 3.5mm with cannulation for 1.2mm K-wire and 4.5 mm with cannulation for 1.6mm K-wire.
- Fully and partly threaded models -

The only modifications that were made are:

- Amendment of screw models with cannulation ।
- Amendment of suitable instruments into instrumentation accordingly. -

#### Substantial Equivalence:

The Cannulated NuGen FX Screw™ has the following similarities to the cleared models of NuGen FX Screw (K012001, K023022):

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

In summary, the Cannulated NuGen™ FX Screw described in this notification is, in our opinion, substantially equivalent to the predicate device. 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2004

Ms. Tuija Annala Director, Quality and Regulatory Affairs Linvatec Biomaterials Ltd. Hermiankatu 6-8 L FIN 33721 Tampere, Finland

Re: K032447

Trade/Device Name: Cannulated 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: March 24, 2004 Received: March 29, 2004

Dear Ms. Annala:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felevelocal above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) (o regars) the enactment date of the Medical Device Amendments, or to commence provide to May 20, 1970, the eccordance with the provisions of the Federal Food, Drug, devices that have been rechasined in asse approval of a premarket approval application (PMA). and Cosmette rear (110) that as nevice, subject to the general controls provisions of the Act. The 1 ou may, morelore, mainer of the Act include requirements for annual registration, listing of general controls provisions of wactice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is bassified (600 a00 70) as . 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 that I 27 Has Intact and regulations administered by other Federal agencies. You must or any I edelar statutes and equirements, 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 - Ms. Tuija Annala

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and my Journe FDA finding of substantial equivalence of your device to a legally premaince notineatem - 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), please 11 you attire office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Oivision 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 N. Mikkelson

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): K032447

Device Name:

Cannulated NuGen™ FX Screw

#### Indications for Use:

The Cannulated 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 Cannulated 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). 3) Highly comminuted fractures, which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.

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 No
(Per 21 CFR 801.109)

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

510(k) Number K032447