MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS

K070906 · Zimmer, Inc. · HWC · May 1, 2007 · Orthopedic

Device Facts

• Record ID: K070906
• Device Name: MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
• Applicant: Zimmer, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: May 1, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• 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

The Zimmer Periarticular Locking Plate System consists of low-profile, anatomically-contoured metallic plates and locking screws. The system is designed for internal fracture fixation. The plates feature threaded holes that accept locking screws to create a stable, fixed-angle construct. The device is used by orthopedic surgeons in a clinical or surgical setting to stabilize bone fractures or osteotomies. By providing a stable, fixed-angle construct, the system facilitates bone healing and stabilization, particularly in challenging cases such as osteopenic bone or comminuted fractures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Metallic bone fixation plates and screws. Features low-profile, anatomically-contoured design with threaded holes for locking screws to create fixed-angle constructs. Materials and manufacturing processes are consistent with previously cleared predicate devices.

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. For prescription use only.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Zimmer Periarticular Plates (K050121)
• 2.7mm Locking Screw (K050121)

Submission Summary (Full Text)

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MAY - I 2007

# Summary of Safety and Effectiveness

Submitter:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Name and Reference:

Predicate Device:

Device Description:

Intended Use:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Mason W. Robbins Specialist, Regulatory Affairs Telephone: [phone] Fax: [phone]

March 30, 2007

Zimmer® Periarticular Locking Plate System

Plate, Fixation, Bone Screw, Fixation, Bone

Plate, Fixation, Bone 21 CFR § 888.3030 Screw, Fixation, Bone 21 CFR § 888.3040

#### Plates

Zimmer Periarticular Plates, manufactured by Zimmer Inc., K050121, cleared January 31, 2005 Screws . 2.7mm Locking Screw, K050121, cleared January

31, 2005, Zimmer, Inc.

The Zimmer Periarticular Locking Plates and Screws are intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically-contoured and has threaded holes which accept locking screws to create a stable, fixed-angle construct.

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.

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Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in a smaller, sans-serif font. The logo is black and white.

Comparison to Predicate Device:

The Zimmer Periarticular Locking Plate System has 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 devices.

Performance Data:

Non-Clinical Performance and Conclusions:

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, formed by a series of curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY - 1 2007

Zimmer, Inc. % Mr. Mason W. Robbins Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K070906 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: Class II Product Code: HWC Dated: March 30, 2007 Received: April 3, 2007

Dear Mr. Robbins:

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 – Mr. Mason W. Robbins

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.html.

Sincerely yours,

Barbara Buehrig
ter.

Mark N. Melkerson 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 - Distal Lateral Fibular Locking Plates and Screws

# Indications for Use:

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

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

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)

Barbara Buchm

Division of General, Restorative, and Neurological Devices

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**510(k) Number**

KO