ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)

K083654 · Zimmer, Inc. · HRS · Feb 26, 2009 · Orthopedic

Device Facts

• Record ID: K083654
• Device Name: ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 26, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Universal Locking System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: - Comminuted fractures - Supracondylar fractures - Extra-articular fractures - Fractures in osteopenic bone - Nonunions - Malunions

Device Story

Zimmer Universal Locking System consists of metallic bone plates and screws for internal fracture fixation. Plate configurations include dual compression, reconstruction, tubular, straight, T, and L shapes. Plates feature figure-8 holes accommodating either standard or locking screws. Device used by surgeons in clinical/OR settings for stabilization of bone fractures and osteotomies. Provides mechanical support to bone segments to facilitate healing. No electronic or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Tivanium (Ti-6Al-4V alloy) and CP Grade Titanium. System includes plates (dual compression, reconstruction, tubular, straight, T, L) and screws. Features figure-8 shaped holes for locking or standard screw fixation. Mechanical bone fixation device.

Indications for Use

Indicated for patients requiring temporary internal fixation and stabilization of osteotomies and fractures, including comminuted, supracondylar, and extra-articular 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 Universal Locking System, 2.7mm Plates and Screws (K063303)

Submission Summary (Full Text)

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# 083654

#### 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. FEB 2 6 2009 P.O. Box 708 Warsaw, IN 46581-0708

Anthony Francalancia, RAC Senior Associate, Regulatory Affairs Telephone: [phone] Fax: [phone]

December 5, 2008

Zimmer® Universal Locking System: 2.7 mm Locking Plates and Screws (Tivanium® Ti-6Al-4V Alloy, CP Grade Titanium)

2.7mm TiULS Locking Plate System

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

Zimmer Universal Locking System, 2.7mm Plates and Screws, manufactured by Zimmer, Inc., K063303, cleared November 22, 2006

The Zimmer Universal Locking System is a plate and screw system intended for internal fracture fixation. The plate selection consists of dual compression, reconstruction, tubular, straight "T" and "L" plate configurations. Plates accommodate either standard or locking screws via figure-8 shaped holes.

The Universal Locking System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

- o Comminuted fractures
- Supracondylar fractures o
- Extra-articular fractures 0
- Fractures in osteopenic bone 0
- Nonunions 0
- Malunions O

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K083654. 2/2

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

The Zimmer Universal Locking System: 2.7mm plates and screws have the same intended use, similar performance characteristics and are similar in design to the predicate devices.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 2 6 2009

Zimmer, Inc. % Mr. Anthony Francalancia P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K083654

Trade/Device Name: Zimmer Universal Locking System: 2.7 mm Locking Plates and Screws (Tivanium Ti-6Al-4V Alloy, CP Grade Titanium)

Regulation Number: 21 CFR 888.3730

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories.

Regulatory Class: II

Product Code: HRS, HWC Dated: February 3, 2009 Received: February 4, 2009

Dear Mr. Francalancia:

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. Anthony Francalancia

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Milliman

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

# 510(k) Number (if known):

Device Name: KO8363636

Zimmer® Universal Locking System: 2.7 mm Locking Plates and Screws (Tivànium® Ti-6Al-4V Alloy, CP Grade Titanium)

## Indications for Use:

The Universal Locking System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

- Comminuted fractures o
- Supracondylar fractures ಂ
- 0 Extra-articular fractures
- Fractures in osteopenic bone 0
- Nonunions 0
- Malunions 0

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)

. 2 (Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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019