PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES

K040593 · Zimmer, Inc. · HRS · Apr 12, 2004 · Orthopedic

Device Facts

• Record ID: K040593
• Device Name: PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Apr 12, 2004
• Decision: SESE
• Submission Type: Traditional
• 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

The Zimmer Periarticular Locking Plate System is a bone fixation device consisting of low-profile, anatomically contoured 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. It is used by surgeons in a clinical or operating room setting to stabilize bone fractures or osteotomies. By providing a rigid, fixed-angle construct, the device maintains alignment of bone fragments during the healing process, which is particularly beneficial in cases of osteopenic bone or complex fractures where traditional plating may be less stable. The device is intended for temporary use until the bone has sufficiently healed.

Clinical Evidence

No clinical data provided. Safety and effectiveness were demonstrated through non-clinical (laboratory) performance testing.

Technological Characteristics

The system consists of metallic bone fixation plates and screws. The design features a low-profile, anatomically contoured plate with threaded holes for locking screws to achieve a fixed-angle construct. Materials and manufacturing processes are similar to existing predicate devices.

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 ECT® Internal Fracture Fixation System
• Synthes Locking Distal Radius Plating System (K012114)
• Synthes Distal Radius Plate System (K982732)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the word "zimmer" in a stylized font. To the left of the word is a circular logo with a stylized letter "Z" inside. The logo and the word "zimmer" are both in black and white. The font used for the word "zimmer" is bold and slightly condensed.

# K040593

## Traditional 510(k) Premarket Notification

## 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>Sr. Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | March 5, 2004 |
| 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 ECT® Internal Fracture Fixation System,<br>Preamendment Device |
| | Synthes Locking Distal Radius Plating System,<br>K012114, cleared 9-28-01 |
| | Synthes Distal Radius Plate System, K982732,<br>cleared 10-8-98 |
| 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 Device: | The Zimmer Periarticular Locking Plate System has<br>the same intended use, has similar performance<br>characteristics, is manufactured from similar<br>materials using similar processes, and is similar in<br>design to the predicate devices. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | The results of non-clinical (laboratory) performance<br>testing demonstrate that the device is safe and<br>effective. |

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APR 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura D. Williams, RAC Senior Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K040593

Trade/Device Name: Zimmer® Periarticular Locking Plate System Regulation Numbers: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HRS, HWC Dated: March 5, 2004 Received: March 8, 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) 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. Milkum

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 e
- Malunions t

Mark N. Millikan

al. Restorative, Divisi and Neurologica Devices

510(k) Number K040593

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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