PERIARTICULAR LOCKING PLATES, 2358 SERIES

K043227 · Zimmer, Inc. · HRS · Dec 10, 2004 · Orthopedic

Device Facts

• Record ID: K043227
• Device Name: PERIARTICULAR LOCKING PLATES, 2358 SERIES
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Dec 10, 2004
• 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 is a metallic bone fixation device used for internal fracture stabilization. System consists of low-profile, anatomically contoured plates with threaded holes designed to accept locking screws. This configuration creates a stable, fixed-angle construct for bone segments. Device is intended for use by surgeons in clinical settings to manage complex fractures, including comminuted and condylar types, as well as nonunions and malunions. By providing rigid fixation, the system supports bone healing and stabilization, particularly in compromised bone quality such as osteopenic bone.

Clinical Evidence

Bench testing only. No clinical data was required or provided for this submission.

Technological Characteristics

Metallic bone fixation plate and screw system. Features low-profile, anatomically contoured plates with threaded holes for locking screws to create fixed-angle constructs. Materials and manufacturing processes are consistent with 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 in patients requiring surgical bone stabilization.

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 (K040593)

Submission Summary (Full Text)

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DEC 1 0 2004

# K043227 (pg 1 of 2)

## 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: | November 18, 2004 |
| Trade Name: | Zimmer® Periarticular Locking Plates |
| Classification Name | Plate, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030 |
| Predicate Device: | Zimmer® Periarticular Locking Plates<br>manufactured by Zimmer, Inc., K040593, cleared<br>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 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. |
| Comparison to Predicate Devices: | The Zimmer Periarticular Locking Plate System has<br>the same intended use, operates with the same<br>fundamental scientific technology, is manufactured<br>from the same materials using similar processes,<br>and is similar in design to the predicate device. |

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Performance Data:

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

Clinical data and conclusions were not needed for this device.

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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 a stylized caduceus or a symbol of health and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 0 2004

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

Re: K043227

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: November 18, 2004 Received: November 22, 2004

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, 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. Noah 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/dsma/dsmamain.html

Sincerely yours,
Mark A. Milburn

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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Image /page/4/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, stylized "Z" enclosed in a circle, followed by the word "zimmer" in lowercase letters. The "Z" is bold and black, contrasting with the white background of the circle, while the word "zimmer" is also in black, creating a clear and recognizable brand identity.

#### 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 .

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)

(Division Sign-Off)
Page 1 of 1
Division of General, Restorative,
and Neurological Devices

510(k) Number K043227

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