ORTHOLOC ANKLE PLATING SYSTEM (APS)

K091243 · Wrightmedicaltechnologyinc · HRS · Jun 26, 2009 · Orthopedic

Device Facts

• Record ID: K091243
• Device Name: ORTHOLOC ANKLE PLATING SYSTEM (APS)
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRS · Orthopedic
• Decision Date: Jun 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORTHOLOC™ Ankle Plating System (APS) is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula.

Device Story

ORTHOLOC™ APS is a bone plate system consisting of straight and pre-contoured plates; accepts nonlocking and locking screws of various lengths/diameters. Used by orthopedic surgeons in clinical settings for internal fixation of distal tibia and fibula fractures, osteotomies, and non-unions. Provides mechanical stabilization of bone segments to facilitate healing. Device is purely mechanical; no software or electronic components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium alloy bone plates and screws; locking and nonlocking screw options; straight and pre-contoured plate geometries; available sterile or non-sterile.

Indications for Use

Indicated for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula in patients requiring orthopedic 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.

Submission Summary (Full Text)

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K091243 . 1/1

## JUN 26 2009

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the ORTHOLOC™ Ankle Plating System.

| Submitted By: | Wright Medical Technology, Inc. |
|-----------------------------------|----------------------------------------|
| Date: | April 16, 2009 |
| Contact Person: | Sarah Holtgrewe |
| | Sr. Regulatory Affairs Specialist |
| Proprietary Name: | ORTHOLOC™ APS |
| Common Name: | Bone Plate System |
| Device Classification Regulation: | 21 CFR 888.3030--Class II |
| Device Product Code & Panel: | HRS: Plate, Fixation, Bone/ Orthopedic |

#### DEVICE INFORMATION

#### A. INTENDED USE

The ORTHOLOCTM Ankle Plating System (APS) is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula.

#### B. DEVICE DESCRIPTION

The ORTHOLOC™ APS consists of straight and pre-contoured plates that accept nonlocking and locking screws of various lengths and diameters. All components are manufactured from titanium alloy and available sterile or non-sterile.

The design features of the ORTHOLOC™ APS are substantially equivalent to the design features of other devices previously cleared for market.

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the ORTHOLOC™ APS are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the ORTHOLOCTM APS is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUN 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technologies, Inc. % Ms. Sarah Holtgrewe 5677 Airline Road Arlington, TN 38002

Re: K091243

Trade/Device Name: ORTHOLOC Ankle Plating System (APS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II Product Code: HRS, HWC Dated: April 27, 2009 Received: April 28, 2009

Dear Ms. Holtgrewe:

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 forth in the quality systems (OS) 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. Sarah Holtgrewe

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrb/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

sincerely, yours,

Barbara Buettner

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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K091243

# Indications for Use

510(k) Number (if known):

Device Name: ORTHOLOC® APS

Indications For Use:

The ORTHOLOC® Ankle Plating System (APS) is intended for fixation of fractures osteotomies, and non-unions of the distal tibia and fibula.

Prescription Use Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aular Breen
Division S

Division Sign-Off Division of Surgical, Orthopedi and Restorative Devices

5.10(k) Number K091243