AXSOS PROXIMAL LATERAL TIBIA LONG PLATES

K123403 · Stryker Trauma AG · HRS · Mar 20, 2013 · Orthopedic

Device Facts

• Record ID: K123403
• Device Name: AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
• Applicant: Stryker Trauma AG
• Product Code: HRS · Orthopedic
• Decision Date: Mar 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AxSOS 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

AxSOS Locking Plate System is a metallic bone fixation device used for long bone fractures. This line extension adds proximal lateral tibia long plates to the existing system. The device is used by surgeons in an operating room setting to stabilize fractures. It functions as a mechanical support system to hold bone fragments in place during the healing process. The plates are available in various lengths and configurations (left/right). The system provides structural stability to the fractured bone, facilitating patient recovery.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including Finite Element Analysis (FEA) and mechanical testing (static strength via axial compression and fatigue strength via axial loading) performed in accordance with ASTM F382-99.

Technological Characteristics

Metallic bone fixation plate. Design includes monoaxial locking mechanism. Testing performed per ASTM F382-99. Risk management conducted per ISO 14971:2007. No software or electronic components.

Indications for Use

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

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

• AxSOS Locking Plate System (K061012)
• Stryker Plating System (K050512)

Submission Summary (Full Text)

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K123403

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# 510(k) Summary AxSOS Locking Plate System

| Proprietary Name: | AxSOS Locking Plate System |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone plates |
| Classification Name and Reference: | Single/multiple component metallic bone fixation<br>appliances and accessories, 21 CFR §888.3030 |
| Regulatory Class: | Class II |
| Product Codes: | 87 HRS: Plate, Fixation, Bone |
| Predicate Devices: | AxSOS Locking Plate System<br>Stryker Plating System |
| For Information contact: | John DeMauro, Regulatory Affairs Consultant<br>Stryke Trauma AG<br>Bohnackerweg 1<br>CH-2545 Selzach<br>Switzerland<br>Phone: [phone] Fax: [phone]<br>[e-mail] |
| Date Prepared: | November 2, 2012 |

#### Description

This Special 510(k) submission is a line extension to address modifications made to the AxSOS Locking Plate System which was cleared in K061012. This line extension is to add tibia long plates to the existing size range of the AxSOS Locking Plate System. These monoaxial long plates will be known as AxSOS Proximal Lateral Tibia Long Plates and will be available in four length sizes in left and right configurations.

## Intended Use

The AxSOS Locking Plate System is intended for use in long bone fracture fixation.

## Indications

The AxSOS 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.

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#### Substantial Equivalence

The AxSOS Proximal Lateral Tibia Long Plates are substantially equivalent to the AxSOS Proximal Lateral Tibia Plates of the AxSOS Locking Plate System cleared under K061012 and to the Proximal Lateral Tibia Plates of the Stryker Plating System (SPS) cleared under K050512 in regards to intended use, design, materials, and operational principles as a bone fixation device.

### Summary of Non-Clinical Testing and Evaluation

Risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. Testing has been performed as per ASTM F382-99 to demonstrate equivalence of the subject device to its predicate device. Finite Element Analysis (FEA), was used to identify the worst case for plate loading. Static strength testing using axial compression was performed. Fatigue strength testing was conducted using axial loading. Results were used to evaluate median fatigue limits and dynamic stiffness, therefore substantiating equivalence to the comparative proximal lateral tibia plates of the Stryker Plating System cleared under K050512.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2013

Stryker Trauma AG % Howmedica Osteonics Corporation Ms. Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430

Re: K123403

Trade/Device Name: AxSOS Proximal Lateral Tibia Long Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: March 1, 2013 Received: March 4, 2013

Dear Ms. Celi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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#### Page 2 - Ms. Estela Celi

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/3/Picture/7 description: The image shows the name "Erin Keith" in a stylized font. The letters "E", "r", "i", and "n" are in a bold, sans-serif font. The letters "K", "e", "i", "t", and "h" are also in a bold font, but they are decorated with geometric shapes and lines. The overall effect is modern and eye-catching.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indication for Use Statement

K123403 Page 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: AxSOS Proximal Lateral Tibia Long Plates

Indications for Use:

The AxSOS 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)

Elizabethi LErank -S

Divison of Orthopedic Devices