ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359

K050121 · Zimmer, Inc. · HRS · Jan 31, 2005 · Orthopedic

Device Facts

• Record ID: K050121
• Device Name: ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 31, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.

Device Story

Zimmer Periarticular Locking Plate System consists of low-profile, anatomically contoured plates and locking screws; creates stable, fixed-angle constructs for internal fracture fixation. Used by surgeons in clinical settings for stabilization of various bone fractures and osteotomies. Device provides mechanical support to bone segments during healing process; benefits patient by maintaining alignment and stability in complex fracture patterns, including those in osteopenic bone.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via non-clinical laboratory performance testing and analysis.

Technological Characteristics

System comprises metallic bone fixation plates and screws. Features anatomically contoured, low-profile plates with threaded holes for locking screw interface to achieve fixed-angle stability. Materials and manufacturing processes are identical to the predicate device.

Indications for Use

Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted, supracondylar, intra-articular, and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.

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

• Zimmer® Periarticular Locking Plates (K042598)

Submission Summary (Full Text)

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JAN \$ 1 2005

# Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Noah J. Bartsch, MS<br>Specialist, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | January 18, 2005 |
| Trade Name: | Zimmer® Periarticular Locking Plates |
| Classification Name | Plate, Fixation, Bone<br>Screw, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030, 3040 |
| Predicate Device: | Zimmer® Periarticular Locking Plates<br>manufactured by Zimmer, Inc., K042598, cleared<br>October 29, 2004. |
| Device Description: | The Zimmer Periarticular Locking Plate System is a<br>plate and screw system intended for internal<br>fracture fixation. The low-profile periarticular<br>locking plate is anatomically contoured and has<br>threaded holes which accept locking screws to<br>create a stable, fixed angle construct. |
| Intended Use: | The Zimmer Periarticular Locking Plate System is<br>indicated for temporary internal fixation and<br>stabilization of osteotomies and fractures, including<br>comminuted fractures, supracondylar fractures,<br>intra-articular and extra-articular condylar fractures,<br>fractures in osteopenic bone, nonunions, and<br>malunions. |

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Comparison to Predicate Devices:

the same intended use, operates with the same fundamental scientific technology, is manufactured from the same materials using similar processes, and is similar in design to the predicate device.

The Zimmer Periarticular Locking Plate System has

Performance Data:

The results of non-clinical (laboratory) performance testing and analysis demonstrate that the device is safe and effective.

Clinical data and conclusions were not needed for this device.

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized wings and body.

JAN 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Noah J. Bartsch, MS Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581

Re: K050121 Trade/Device Name: Zimmer® Periarticular 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: January 18, 2005 Received: January 19, 2005

Dear Mr. Bartsch:

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. Iisting 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 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.

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Page 2 -- Mr. Noah J. Bartsch, MS

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/industry/support/index.huml.

Sincerely yours,

Mark A. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosurc

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# Indications for Use

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

### Device Name:

Zimmer® Periarticular Locking Plate System

### Indications for Use:

The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

- Comminuted fractures
- Supracondylar fractures .
- Intra-articular and extra-articular condylar fractures .
- . Fractures in osteopenic bone
- . Nonunions
- Malunions .

Mark A. Mckissen

Division of General, Restorative. and Neurologica. Devi

510(k) Number K050121

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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