UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS

K060710 · Zimmer, Inc. · HWC · Apr 26, 2006 · Orthopedic

Device Facts

• Record ID: K060710
• Device Name: UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
• Applicant: Zimmer, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Apr 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• 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 and malunions.

Device Story

Zimmer Universal Locking System is a metallic plate and screw system for internal fracture fixation. Plates feature figure-8 shaped holes accommodating standard or locking screws; configurations include dual compression, reconstruction, tubular, straight 'T', and oblique 'T'. Used by orthopedic surgeons in clinical settings for stabilization of various fracture types and osteotomies. Device provides mechanical support to bone segments during healing process; benefits include stabilization of fractures in compromised bone (osteopenic) and management of complex fracture patterns.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Metallic bone fixation plates and screws. Features figure-8 shaped holes for locking or standard screw accommodation. Configurations: dual compression, reconstruction, tubular, straight 'T', and oblique 'T'.

Indications for Use

Indicated for 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

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® ECT® Internal Fracture Fixation system
• Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684)

Submission Summary (Full Text)

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Traditional 510(k) Premarket Notification

# Summary of Safety and Effectiveness

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| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anthony Francalancia<br>Senior Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | March 15, 2006 |
| Trade Name: | Zimmer® Universal Locking System |
| Common Name: | 3.5mm Locking Plate System |
| Classification Name<br>and Reference: | Plate, Fixation, Bone (21 CFR § 888.3030)<br>Screw, Fixation, Bone (21 CFR § 888.3040) |
| Predicate Devices: | Zimmer® ECT® Internal Fracture Fixation system<br>(Pre-amendment device).<br>Synthes Small Fragment Dynamic Compression<br>Locking (DCL) System (K000684, cleared April 28,<br>2000). |
| Device Description: | The Zimmer Universal Locking System is a plate<br>and screw system intended for internal fracture<br>fixation. The plate selection consists of dual<br>compression, reconstruction, tubular, straight "T"<br>and oblique "T" configurations. Plates<br>accommodate either standard or locking screws via<br>figure-8 shaped holes. |
| Intended Use: | The Universal Locking System is indicated for<br>temporary internal fixation and stabilization of<br>osteotomies and fractures, including comminuted<br>fractures, supracondylar fractures, extra-articular<br>fractures, fractures in osteopenic bone, nonunions<br>and malunions. |
| Comparison to Predicate Device: | The Zimmer Universal Locking System plates have<br>the same intended use, similar performance |

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characteristics, are manufactured from similar materials and are similar in design to the predicate devices.

### Performance Data:

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 6 2005

Zimmer, Inc. c/o Mr. Anthony Francalancia Senor Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K060710

Trade/Device Name: Zimmer Universal 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. HWC Dated: March 15, 2006 Received: March 16, 2006

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 max 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. Your 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

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#### Page 2 - Mr. Anthony Francalancia

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. 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,

Nil RP Ozil
Mark N. Melkerson

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 Universal Locking Plate System

#### Indications for Use:

The Universal Locking Plate 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 ●

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)**

Niel R.C. Ogle for mxp

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Division of General, Restorative, and Neurological Devices

510(k) Number K060710