BIOMET VARIABLE LOCKING PLATE SYSTEM

K071325 · Biomet Trauma · HRS · Jul 26, 2007 · Orthopedic

Device Facts

• Record ID: K071325
• Device Name: BIOMET VARIABLE LOCKING PLATE SYSTEM
• Applicant: Biomet Trauma
• Product Code: HRS · Orthopedic
• Decision Date: Jul 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Biomet Variable Locking Plate System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.

Device Story

Internal bone fixation system; comprised of Ti-6Al-4V plates and screws. Used by surgeons for stabilization of pelvic, small, and long bone fractures or post-osteotomy fixation. Provides mechanical support to bone segments to facilitate healing/arthrodesis. Device is implanted during surgical procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence based on engineering analyses and comparison to predicate devices.

Technological Characteristics

Material: Ti-6Al-4V. Components: Metallic bone plates and screws. Design: Variable locking plate system for internal bone fixation. Mechanical fixation principle.

Indications for Use

Indicated for adult or pediatric patients requiring pelvic, small, or long bone fracture fixation, or fixation following osteotomy for deformity correction or arthrodesis. Includes internal fixation of tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand, and middle foot bones.

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

• EBI Anterior Cervical Plate System (Cyprus) (K060379)
• IQL Stainless Steel Bone Plates and Screws (K020221)

Submission Summary (Full Text)

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K071325

JUL 26 2007

## 510(k) Summary

| Preparation Date: | July 10, 2007 |
|----------------------|---------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Trauma (formerly known as EBI Trauma)<br>100 Interpace Parkway<br>Parsippany, NJ 07054 |
| Contact Person: | Debra L. Bing<br>Director, Requlatory Affairs<br>Biomet Trauma<br>973.299.9300 |
| Proprietary Name: | Biomet Variable Locking Plate System |
| Common Name: | Metallic bone plates and screws |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories,<br>21 CFR \$888.3030 |
| Product Code(s): | HRS, HWC |

## Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| EBI Anterior Cervical Plate System (Cyprus) | K060379 | EBI, L.P. |
|---------------------------------------------|---------|-------------------------|
| IQL Stainless Steel Bone Plates and Screws | K020221 | Biomet Orthopedics, Inc |

Device Description: The Biomet Variable Locking Plate System is an internal fixation system comprised of Ti-6Al-4V and consisting of various-sized plates and screws.

Indications for Use: The Biomet Variable Locking Plate System is used for adult or pediatric patients as indicated for pelvic, small and long bone fraction and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.

Summary of Technologies: The technological characteristics of the Biomet Variable Locking Plate System are the same as, or similar to, the predicate devices.

Non-Clinical Testing: Engineering analyses comparing the Biomet Variable Locking Plate System to a predicate device were conducted to determine substantial equivalence. The results indicated that the Biomet Variable Locking Plate System was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc. unless otherwise noted.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2007

Biomet Trauma % Ms. Susan Alexander Senior Regulatory Specialist P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K071325

Trade/Device Name: Biomet Variable 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: May 9, 2007 Received: May 10, 2007

Dear Ms. Alexander:

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

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Page 2 - Ms. Susan Alexander

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/industry/support/index.html.

Sincerely yours,

Harbare Muchimp

for

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

5:10(k) Number (if known): K07 | 325

Device Name: Biomet Variable Locking Plate System

Indications For Use:

The Biomet Variable Locking Plate System is used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ NO (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)

Aarbai bonem

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

510(k) Number k021324

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