HIPLOC COMPRESSION HIP SCREW

K080685 · Biomet Manufacturing, Inc. · JDO · Aug 15, 2008 · Orthopedic

Device Facts

• Record ID: K080685
• Device Name: HIPLOC COMPRESSION HIP SCREW
• Applicant: Biomet Manufacturing, Inc.
• Product Code: JDO · Orthopedic
• Decision Date: Aug 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for the HipLOC™ Compression Hip Screw include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures.

Device Story

HipLOC™ Compression Hip Screw is an internal fracture fixation device for proximal femur fractures. It provides alignment and stabilization for intracapsular, intertrochanteric, and subtrochanteric fractures. Used by orthopedic surgeons in clinical/surgical settings. Device functions as a mechanical implant to secure bone fragments. No software or electronic components involved.

Clinical Evidence

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

Technological Characteristics

Internal bone fixation device; metallic construction; design, sizes, and materials are similar or identical to predicate compression hip screw systems.

Indications for Use

Indicated for patients requiring open reduction and internal fixation of proximal femur fractures, including intracapsular, intertrochanteric, and subtrochanteric fractures.

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

• Biomet® Compression Hip Screw System (K781389)
• DHS® System, Synthes (K981757)

Submission Summary (Full Text)

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# 510(k) Summary

# AUG 1 5 2008

| Preparation Date: | June 17, 2008 |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| 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: | HipLOC™ Compression Hip Screw |
| Common Name: | Internal fracture fixation device |
| Classification Name: | Device, Fixation, Proximal Femoral, Implant JDO (CFR 888.3030) |

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet® Compression Hip Screw System, K781389; DHS® System, Synthes, K981757.

## Device Description:

The HipLOC™ Compression Hip Screw is designed as an internal fixation device to provide alignment and strong stabilization for fractures of the proximal femur.

#### Intended Use:

Indications for the HipLOC™ Compression Hip Screw include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures.

## Summary of Technologies:

The technological characteristics (materials, sizes, design) 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 DHS® System which belongs to Synthes.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 1 5 2008

Re: K080685 Trade/Device Name: HipLOC™ Compression Hip Screw Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDO, KTT Dated: July 10, 2008 Received: July 14, 2008

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 (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 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 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 yours.

Mark N. Wilkerson

- 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: HipLOC™ Compression Hip Screw

Indications for Use:

Indications for the HipLOC™ Compression Hip Screw include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures.

Prescription Use __ YES (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)

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Sarliare Bucectofr MM
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K080685