BIOMET FEMORAL LOCKING NAIL SYSTEM

K072161 · Biomet Manufacturing Corp · HSB · Sep 20, 2007 · Orthopedic

Device Facts

• Record ID: K072161
• Device Name: BIOMET FEMORAL LOCKING NAIL SYSTEM
• Applicant: Biomet Manufacturing Corp
• Product Code: HSB · Orthopedic
• Decision Date: Sep 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are to be implanted into the femur for alignment, stabilization, fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis.

Device Story

Biomet Femoral Locking Nail System consists of intramedullary nails for antegrade and retrograde femoral applications. Device features internal locking/compression mechanism and multiple screw configurations for fixation. Implanted by surgeons in clinical settings to stabilize femoral fractures, correct deformities via osteotomy, or perform arthrodesis. Provides mechanical support to bone segments to facilitate healing and alignment.

Clinical Evidence

No clinical data provided; substantial equivalence based on non-clinical laboratory testing.

Technological Characteristics

Intramedullary nail system; titanium construction; internal locking/compression mechanism; antegrade and retrograde application configurations. No software or electronic components.

Indications for Use

Indicated for patients requiring femoral alignment, stabilization, and fixation of fractures due to trauma or disease, fixation of femurs following osteotomy for deformity correction, and arthrodesis.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Holland Nail (K983641)
• Uniflex Nailing System (K982953)
• T2 Supracondylar Nailing System (K023267)

Submission Summary (Full Text)

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SEP 2 0 2007

## 510(k) Summary

| Preparation Date: | August 3, 2007 |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Trauma (aka EBI; names may be used interchangeably)<br>100 Interpace Parkway<br>Parsippany, NJ 07054 |
| Contact Person: | Becky Earl/Debra L. Bing |
| Proprietary Name: | Biomet® Femoral Locking Nail System |
| Common Name: | Titanium intramedullary nails |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories (CFR 888.3020) |

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K983641, Holland Nail™ Ecgany Flamet); K982953, Uniflex® Nailing System (Biomet); and K023267, T2™ Supracondylar Nailing System (Howmedica/Stryker)

### Device Description:

The Biomet® Femoral Locking Nail System is a set of intramedullary nails, designed for both antegrade and retrograde applications. Features include an internal locking/compression mechanism and numerous screw configurations to enable nail fixation.

### Intended Use:

The Biomet® Femoral Locking Nail is intended to be used as follows:

These devices are to be implanted into the femur for alignment, stabilization, fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis.

### Summary of Technologies:

Summary of Technological characteristics (materials, design, sizing, aritculating surface, indications) of the Biomet® Femoral Locking Nail System are similar or identical to the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

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

All trademarks are property of Biomet, Inc., except for the T2™ Supracondylar Nailing System which belongs to Howmedica/Styker

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three stripes forming its body and wing, and it faces to the right. The seal is in black and white.

SEP 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Becky Earl P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K072161

Trade/Device Name: Biomet® Femoral Locking Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 3, 2007 Received: August 6, 2007

Dear Ms. Earl:

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. Becky Earl

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

ChavargBucelund

Mark N. Melkerso 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):_ K 0 7 2 1 6 l

Device Name: Biomet® Femoral Locking Nail System

Indications For Use: These devices are to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis.

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)

Barbara Buehr

vision Sigr Division of General, Restorative, and Neurological Devices

**510(k) Number.** K072161

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