ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM

K111039 · Zimmer, Inc. · HRS · May 19, 2011 · Orthopedic

Device Facts

• Record ID: K111039
• Device Name: ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: May 19, 2011
• 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 consists of low-profile, anatomically contoured metallic plates with threaded holes; screws engage and lock into plates at fixed angles. Used by surgeons for temporary internal fixation and stabilization of bone fractures and osteotomies. Device provides mechanical support to bone segments during healing. This submission introduces sterile-packaged versions of previously cleared non-sterile devices; no changes to design, materials, or operating principles.

Clinical Evidence

No clinical data provided. Bench testing only, including sterilization validation (gamma dose 20kGy, SAL 10^-6), shelf-life testing (accelerated aging to 10 years), and sterile packaging integrity testing.

Technological Characteristics

Metallic bone fixation plates and screws; low-profile, anatomically contoured design; threaded locking mechanism. Sterilization via gamma irradiation (minimum 20kGy).

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 Plate System (K040593)
• Zimmer Periarticular Locking Plate System (K042598)
• Zimmer Periarticular Locking Plate System (K043227)
• Zimmer Periarticular Locking Plate System (K043560)
• Zimmer Periarticular Locking Plate System (K050121)
• Zimmer Periarticular Locking Plate System (K051098)

Submission Summary (Full Text)

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K111039(pg 1/2)

Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font. The logo is black and white.

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

# MAY 1 9 2011

### 510(k) Summary

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

Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: [phone] Fax: [phone]

Date:

Sponsor:

Trade Name:

Common Name:

Contact Person:

Classification Names and References:

Predicate Devices:

Device Description:

Intended Use:

April 13, 2011

Zimmer Periarticular Locking Plate System

Temporary Internal Fixation Devices

Single/multiple component metallic bone fixation appliances and accessories - 21 CFR 888,3030. Smooth or threaded metallic bone fixation fastener - 21 CFR 888.3040

Zimmer Periarticular Locking Plate System - K040593 (cleared 4/12/2004), K042598 (cleared 10/29/2004), K043227 (cleared 12/10/2004), K043560 (cleared 1/21/2005), K050121 (cleared 1/31/2005) and K051098 (cleared 7/7/2005)

The Zimmer Periarticular Locking Plate System is a plate and screw system. The low-profile periarticular plates are anatomically contoured with threaded holes to engage and "lock" the screws at a fixed angle relative to the plate.

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

23

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Comparison to Predicate Device:

Identical to the predicate devices - this submission is to add the sterile version of non-sterile devices

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

- . Sterilization Validation - To demonstrate that at a minimum gamma dose of 20kGy the devices can be terminally sterilized to a SAL greater than or equal to 10-6.
- . Shelf Life - Accelerated aging showed that the product has a shelf life of 10 years.
- . Sterile Packaging - To withstand normal distribution and storage conditions and maintain the sterile barrier properties throughout the specified product shelf life.

Except for the sterilization status, sterile packaging and the addition of sterile text on the labels and in the package inserts, the sterile devices included in this submission are identical to their associated non-sterile predicate devices. The addition of sterile versions did not change the intended use or the fundamental scientific technology of any of the devices. Each sterile device uses the same operating principle and incorporates the same design and basic labeling.

In summary, the sterile devices described in this submission are substantially equivalent to their non-sterile counterparts.

Clinical Performance and Conclusions:

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 and 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 emblem featuring a stylized depiction of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAY 1 9 2011

Zimmer, Inc. % Stephen H. McKelvey Senior Project Manager Trauma Regulatory Affairs P.O. Box 708 Warsaw, IN 46581

Re: K111039

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: HRS, HWC Dated: April 13, 2011 Received: April 19, 2011

Dear Mr. McKelvey:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page - 2 - Stephen H. McKelvev

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

A.S. VS. R. h
for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### K040593, K042598, K043227, K043560, K050121, 510(k) Number (if known): K051098

### 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, and .
- 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)

sor M. Meukerson

(Division Sign Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111039