AXSOS PLUS LOCKING PLATE SYSTEM

K061012 · Howmedica Osteonics Corp. · HRS · May 19, 2006 · Orthopedic

Device Facts

• Record ID: K061012
• Device Name: AXSOS PLUS LOCKING PLATE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: May 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AxSOS™ Plus Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur.

Device Story

The AxSOS™ Plus Locking Plate System is a line extension of the Stryker® Locked Plating System, consisting of metallic bone plates and screws for internal fracture fixation. The plates feature both locking and non-locking holes, as well as holes for Kirschner wires to assist in primary plate and fracture fixation or as suture anchors. The device is used by surgeons in a clinical or operating room setting to stabilize long bone fractures. By providing rigid internal fixation, the system facilitates bone healing and restores structural integrity to the fractured limb. The device is provided sterile or non-sterile.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence was established through FEA and mechanical strength testing comparing the subject plates to the predicate system.

Technological Characteristics

Metallic bone fixation system. Components include bone plates and screws with locking and non-locking holes. Features holes for Kirschner wires. Materials and design are consistent with the predicate Stryker® Locked Plating System. Mechanical performance validated via FEA and bench testing.

Indications for Use

Indicated for fixation of long bone fractures, including humerus, tibia, and femur, in patients requiring internal bone fixation.

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

• Stryker® Locked Plating System

Submission Summary (Full Text)

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K061012

## 510(k) Summary of Safety and Effectiveness AxSOSTM Plus Locking Plate System

| Proprietary Name: | AxSOS ™ Plus 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>Francisco Haro, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | April 10, 2006 |

## Description

This submission is a line extension to the Stryker® Locked Plating System for various types of locking plates. Plates will be based on the design of the monoaxial plates in the Stryker® Locked Plating System. The subject plates have locking and non-locking holes. 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.

Indications:

The AxSOS™ Plus Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur.

Substantial Equivalence:

The AxSOS™ Plus Locking Plate System is substantially equivalent to the Stryker® Locked Plating System in regards to intended use, design, materials, and operational principles as internal fixation components. FEA and mechanical testing was conducted to compare the strength of the new plates to the predicate plates. The results demonstrate that the subject components are substantially equivalent in strength to the predicate components.

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Public Health Service ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 9 2006

DEPARTMENT OF HEALTH & HUMAN SERVICES SECTION CONSULTION

Howmedica Osteonics Corporation % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K061012

Trade/Device Name: AxSOS™ Plus 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: HRS Dated: April 10, 2006 Received: April 12, 2006

Dear Mr. Haro:

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, 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

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## Page 2 – Mr. Francisco Haro

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.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Hubert Lemons

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: AxSOS™ Plus Locking Plate System

Indications for Use:

The AxSOS™ Plus Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur.

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 Evaluation (ODE)

Device Evaluation (ODE)

Hubert Lense

Division Sign-O Division of General, Restora and Neurological Devices

**510(k) Number** K061012

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