BIOMET TIBIAL LOCKING NAIL SYSTEM

K063570 · Biomet Manufacturing Corp · HSB · Feb 27, 2007 · Orthopedic

Device Facts

• Record ID: K063570
• Device Name: BIOMET TIBIAL LOCKING NAIL SYSTEM
• Applicant: Biomet Manufacturing Corp
• Product Code: HSB · Orthopedic
• Decision Date: Feb 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomet® Tibial Locking Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and arthrodesis.

Device Story

Biomet Tibial Locking Nail System; intramedullary nail for tibial canal insertion. Features proximal/distal bends for anatomical fit; internal locking/compression mechanism; dynamization/locking slot; multiple screw configurations for fixation. Used by orthopedic surgeons in clinical/OR settings for fracture management and bone reconstruction. Device provides mechanical stabilization of long bones; aids healing through alignment and fixation. No software or electronic components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Intramedullary nail; titanium construction; proximal and distal bends; internal locking/compression mechanism; dynamization/locking slot; screw fixation configurations. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring alignment, stabilization, or fixation of long bone fractures caused by trauma or disease, or fixation following osteotomy for deformity correction or 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

• Uniflex® Tibial Nail (Low Profile) (K982953)

Submission Summary (Full Text)

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K063570

FEB 2 7 2007

## 510(k) Summary

| Preparation Date: | November 28, 2006 |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| 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® Tibial Locking Nail System |
| Common Name: | Titanium intermedullary nails |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories (CFR 888.3020) |

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Titanium Intramedullary Rods-Various (Uniflex® Tibial Nail (Low Profile) - K982953 (Biomet Inc.)

#### Device Description:

The Biomet® Tibial Locking Nail System is an intramedullary nail, designed to be inserted through the proximal tibia and proceed down the intramedullary canal of the tibia. The nail has both a proximal and distal bend to accommodate the anatomy of the tibia. Features include an internal locking/compression mechanism, a dynamization/locking slot, and numerous screw configurations to enable nail fixation.

#### Intended Use:

The Biomet® Tibial Locking Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and arthrodesis.

#### Summary of Technologies:

The technological characteristics (materials, design, sizinq, aritculating surface, indications) of the Biomet® Tibial Locking Nail System are similar or identical to the predicate device.

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.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top half of the circle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. c/o Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581

1-13 9 7 2007

Re: K063570

Trade/Device Name: Biomet® Tibial Locking Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: November 28, 2006 Received: November 29, 2006

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

Sincerely yours

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:

Indications For Use:

The Biomet® Tibial Locking Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and 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)

Signature

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

510(k) Number

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