PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359

K043560 · Zimmer, Inc. · HRS · Jan 21, 2005 · Orthopedic

Device Facts

• Record ID: K043560
• Device Name: PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, and malunions.

Device Story

Zimmer Periarticular Locking Plate System is a metallic bone fixation device consisting of anatomically contoured, low-profile plates with threaded holes and locking screws. Designed for internal fracture fixation, the system creates a stable, fixed-angle construct to stabilize bone segments. Used by orthopedic surgeons in clinical settings for fracture management; the device provides mechanical support to facilitate bone healing. It is intended for temporary use in patients with various fracture types, including those in osteopenic bone.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Metallic bone fixation system comprising plates and screws. Features anatomically contoured, low-profile design with threaded holes for locking screw interface to create fixed-angle constructs. Class II device (21 CFR 888.3030, 888.3040).

Indications for Use

Indicated for patients requiring temporary internal fixation and stabilization of osteotomies and fractures, including comminuted, supracondylar, intra-articular, and extra-articular condylar fractures, as well as 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 Plate System (K040593)

Submission Summary (Full Text)

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IAN 2 】 2005

# Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laura D. Williams, RAC<br>Manager, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | December 23, 2004 |
| Trade Name: | Zimmer® Periarticular Locking Plate System |
| Classification Name: | Plate, Fixation, Bone<br>Screw, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030,3040 |
| Predicate Device: | Zimmer Periarticular Locking Plate System,<br>K040593, cleared April 12, 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 Periarticular Locking Plate System is indicated<br>for temporary internal fixation and stabilization of<br>osteotomies and fractures, including comminuted<br>fractures, supracondylar fractures, intra-articular<br>and extra-articular condylar fractures, fractures in<br>osteopenic bone, nonunions, and malunions. |
| Comparison to Predicate Device: | The Zimmer Periarticular Locking Plate System has<br>the same intended use, has similar performance<br>characteristics, operates using the same fundamental<br>scientific technology, is manufactured from the<br>same materials using the same processes, and is<br>similar in design to the predicate device. |

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Performance Data (Nonclinical and/or Clinical):

1.

Non-Clinical Performance and Conclusions:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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JAN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura D. Williams, RAC Manager, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581

Re: K043560

Trade/Device Name: Zimmer® Periarticular 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: December 23, 2004 Received: December 27, 2004

Dear Ms. Williams:

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 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 - Ms. Laura D. Williams, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegill maneting of substantial equivalence of your device to a legally prematics noticate 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 If you desire specific at 1240) 276-0115. Also, please note the regulation entitled, eonidor the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermation on your response 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.

Mark A. Melleuson

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

Enclosure

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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. Milkerer

Division of General, Restorative, and Neurological Devices

510(k) Number K043560

Prescription Use _X_ (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 if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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