VARIAX LOCKING PLATE SYSTEM

K060613 · Howmedica Osteonics Corp. · KTT · Apr 21, 2006 · Orthopedic

Device Facts

• Record ID: K060613
• Device Name: VARIAX LOCKING PLATE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Apr 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VariAx™ Locking Plate System is intended for use in the temporary stabilization of long bone fractures, including but not limited to: Proximal and distal fractures including joint fractures of the humerus, tibia and other long bones Metaphyseal, supracondylar, peri-articular, intra-articular, intra-articular condylar fractures Diaphyseal fractures Ankle fractures Simple, comminuted and depression fractures Non-unions and malunions Osteotomies and bone reconstruction Fractures in normal or osteoporotic bone

Device Story

VariAx™ Locking Plate System consists of metallic bone plates and screws for temporary internal fixation of long bone fractures. System features locking and non-locking holes; utilizes Ø4.0mm Universal Screws (fully threaded self-tapping or partially threaded). Plates incorporate polyaxial locking mechanism and holes for Kirschner wires or suture anchors. Device used by orthopedic surgeons in clinical/OR settings to stabilize fractures via compression or lag screw technique. Output is mechanical stabilization of bone segments. Benefits include restoration of alignment and support for healing in normal or osteoporotic bone.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by FEA and mechanical testing comparing strength of subject components to predicate devices.

Technological Characteristics

Metallic bone fixation system; includes locking/non-locking plates and screws. Features polyaxial locking mechanism. Materials are metallic (specific alloys not detailed). Components available sterile and non-sterile. Mechanical fixation via screws and Kirschner wires.

Indications for Use

Indicated for temporary stabilization of long bone fractures (humerus, tibia, etc.) in patients requiring surgical fixation for proximal/distal, metaphyseal, supracondylar, peri-articular, intra-articular, diaphyseal, or ankle fractures; also indicated for non-unions, malunions, osteotomies, and bone reconstruction in normal or osteoporotic bone.

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

• Numelock™ II System
• Stryker® Locked Plating System
• Stryker® Plating System

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness VariAx™ Locking Plate System

APR 2 1 2006

| Proprietary Name: | VariAx™ Locking Plate System |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone plates and screws |
| Classification Name/Reference: | Single/multiple component metallic bone fixation<br>appliances and accessories, 21 CFR §888.3030 |
| Device Product Code: | 87 KTT |
| Proposed Regulatory Class:<br>For Information contact: | Class II<br>Vivian Kelly, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | March 6, 2006 |

## Description

This submission is a line extension to the Numelock™ II System and the Stryker® Locked Plating System for various types of locking plates, locking screws and non-locking screws. Plates will be based on the design of the monoaxial plates in the Stryker® Locked Plating System and the polyaxial locking mechanism of the Numelock 10 II plates. The subject plates have locking and non-locking holes and are used with the Ø4.0mm VariAx™ Universal Screws. There is a fully threaded, self-tapping screw and a partially threaded style of screw. All screws will be available sterile and non-sterile. The plates also have holes for standard Kirschner wires to enhance primary plate and fracture fixation or they can be used as suture anchors. Also, compression of the can be applied to the plate using the Universal Screw and act as a lag screw by pulling the bone toward the plate.

## Indications:

The VariAx™ Locking Plate System is intended for use in the temporary stabilization of long bone fractures, including but not limited to:

- Proximal and distal fractures including joint fractures of the humerus, tibia and other long . bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, intra-articular condylar fractures �
- Diaphyseal fractures .
- . Ankle fractures
- Simple, comminuted and depression fractures .
- � Non-unions and malunions
- Osteotomies and bone reconstruction .
- Fractures in normal or osteoporotic bone .

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Substantial Equivalence:

The VariAx™ Locking Plate System is substantially equivalent to other plating systems in regards to intended use, design, materials, and operational principles as internal fixation components such as the Numelock™ II System, Stryker® Locked Plating System and the Stryker® Plating System. FEA and mechanical testing was conducted to compare the strength of the new plates and screws to other plates and screws on the market. The results demonstrate that the subject components are substantially equivalent in strength to the predicate components.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2005

Howmedica Osteonics Corporation c/o Ms. Vivian Kelly Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K060613

Trade/Device Name: VariAx™ Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 6. 2006 Received: March 7, 2006

Dear Ms. Kelly:

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 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. Ilsting 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 vour 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

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Page 2 - Ms. Vivian Kelly

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. 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), please contact the 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 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.ida.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Haki Limes V.

Mark N. Melkerson 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): ____________________________________________________________________________________________________________________________________________________

Device Name: VariAxTM Locking Plate System

Indications for Use:

The VariAx™ Locking Plate System is intended for use in the temporary stabilization of long bone fractures, including but not limited to:

- Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, intra-articular condylar . fractures
- Diaphyseal fractures .
- . Ankle fractures
- . Simple, comminuted and depression fractures
- . Non-unions and malunions
- . Osteotomies and bone reconstruction
- Fractures in normal or osteoporotic bone ●

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device

Michel (emer)
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K060013

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