AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS

K092419 · Howmedica Osteonics Corp. · HRS · Sep 1, 2009 · Orthopedic

Device Facts

• Record ID: K092419
• Device Name: AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS
• Applicant: Howmedica Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 1, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

Device Story

AxSOS® Locked Plating System is a metallic bone fixation system used for long bone fracture stabilization. This line extension modifies 3mm locking inserts used within the system. The device is intended for use by orthopedic surgeons in a clinical or surgical setting. It functions as a mechanical fixation appliance to stabilize fractures, facilitating bone healing. The system is implanted during surgery; it does not involve electronic inputs, software, or automated processing. The healthcare provider uses the plates and screws to provide structural support to fractured bone segments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation system (plates and screws) constructed from stainless steel. The system utilizes a monoaxial locking mechanism. No electronic components, software, or energy sources are involved.

Indications for Use

Indicated for fixation of long bone fractures in patients requiring surgical stabilization of the distal radius, proximal humerus, distal tibia, proximal tibia, or distal femur.

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

• K050512
• K060514
• K060798
• K061012

Submission Summary (Full Text)

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#### KO92419

AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts

Special 510(k)

# 510(k) Summary of Safety and Effectiveness: AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts

#### Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

For Information contact:

Date Summary Prepared:

Device Identification Proprietary Name:

Common Name: Classification Name and Reference:

Device Product Code:

SEP - 1 2009

Howmedica Osteonics Corp 325 Corporate Drive Mahwah. NJ 07430

Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate. Drive Mahwah, NJ 07430 Phone: [phone] Fax: [phone]

August 31, 2009

AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts Bone plates and screws Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030 Smooth or Threaded metallic bone fixation fastener, 21 CFR \$888.3040 87 HRS: Plate, Fixation, Bone

87 HWC: Screw, Fixation, Bone

#### Description:

This Special 510(k) submission is intended to address modifications to the predicate Stryker Locking Inserts.

The AxSOS® Locking Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 3mm Locking Inserts to which changes are being made.

#### Intended Use:

The AxSOS® Locked Plating System Line Extension of 3mm Locking Insert modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below.

2092419 Page 1/2

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## Indications for Use:

The AxSOS® SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intented for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

## Statement of Technological Comparison:

The subject and predicate devices are made from Stainless Steel. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject AxSOS® System to the predicate device K050512, K060514, K060798, and K061012.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

Howmedica Osteonics Corp. % Ms. Melissa A. Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, NJ 07430

SEP - 1 2009

Re: K092419

Trade/Device Name: AxSOS® Locked Plating System (Line Extension of 3mm Locking Inserts) Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II

Product Code: HRS, HWC

Dated: August 4, 2009

Received: August 6, 2009

Dear Ms. Matarese:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Melissa A. Matarese

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Barbara Buchm

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

Enclosure

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# Indications for Use

### 510(k) Number (if known): KO92419

Device Name: AxSOS® Locked Plating System Line Extension of 3mm Locking Inserts

Indications For Use:

The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.

Prescription Use X ·

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

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Smitta for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092419