TROCHANTERIC NAIL SYSTEM

K042325 · DePuy Orthopaedics, Inc. · HSB · Sep 8, 2004 · Orthopedic

Device Facts

• Record ID: K042325
• Device Name: TROCHANTERIC NAIL SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.

Device Story

Intramedullary fixation system for proximal femoral fractures; components include intramedullary nail, lag screw, end cap, and optional anti-rotation screw. Lag screw provides dynamic fracture compression; anti-rotation screw provides rotational stability; end cap prevents bone ingrowth. Used by orthopedic surgeons in clinical/surgical settings. Device stabilizes bone segments to facilitate healing in stable/unstable fractures, including osteoporotic and complex diaphyseal cases.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V ELI). Components: Intramedullary nail, lag screw, end cap, anti-rotation screw. Function: Intramedullary fixation rod for bone fracture stabilization. Design: Dynamic compression via lag screw; rotational stability via optional anti-rotation screw.

Indications for Use

Indicated for patients with stable/unstable proximal femoral fractures, including pertrochanteric, intertrochanteric, high subtrochanteric, and combinations thereof. Long nail version indicated for pertrochanteric fractures with shaft fractures, pathologic fractures in osteoporotic bone, long subtrochanteric fractures, ipsilateral femoral fractures, non-unions, malunions, and revision procedures.

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

• DePuy Trochanteric Nail (K010780)
• DePuy Trochanteric Nail (K013563)

Submission Summary (Full Text)

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| 510(k) Summary | | K042325<br>page 1 of 2 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 | |
| 510(K) CONTACT: | Steve Kahn<br>RA Director, Trauma and Extremities<br>Telephone: [phone]<br>Fax: [phone] | |
| DATE PREPARED: | July 30, 2004 | |
| TRADE NAME: | Trochanteric Nail System | |
| COMMON NAME: | Bone fixation device | |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3020:<br>Intramedullary fixation rod<br>Description: Rod, Fixation, Intramedullary and<br>Accessories, Metallic and Non-collapsible | |
| DEVICE PRODUCT CODE: | HSB<br>No performance standards have been established<br>under section 514 of the Federal Food, Drug, and<br>Cosmetic Act for intramedullary nails | |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | DePuy Trochanteric Nail (K010780)<br>DePuy Trochanteric Nail (K013563) | |

## DEVICE DESCRIPTION:

The Trochanteric Nail System consists of an intramedullary nail, lag screw, end cap, and optional anti-rotation screw, all manufactured from titanium alloy (Ti-6Al-4V ELI), which are used to treat fractures in the proximal portion of the femur.

## INTENDED USE AND INDICATIONS:

The lag screw provides dynamic compression of the fracture; the anti-rotation screw can be used to prevent the rotation of the bone fracture segments, and the end cap prevents bone ingrowth. It is estimated that the AR screw is required in only five to ten percent of the cases where additional rotational stability of the fracture is required.

The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures,

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K042325
page 2 of 2

ipsilateral femoral fractures, proximal or distal non-unions and malunic procedures.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on the same Intended Use, Indications for Use, materials, sterilization processes and Dascu on the same intended 050, mercanone for of the rest that the subject Trochanteric Sillifiantes of technological and goother. In the previously cleared DePuy predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design resembling an abstract human figure or a symbol representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP = 8 2004

Mr. Steve A. Kahn Regulatory Affairs Director, Trauma and Extremities DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K042325

Trade/Device Name: Trochanteric Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 12, 2004 Received: August 27, 2004

Dear Mr. Kahn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated) is the enactment date of the Medical Device Amendments, or to conimered prior to that 20, 2017 , 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 I ou may, thereforminens of the Act include requirements for annual registration, listing of general octurely profisevring 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 rr your device is elasellion (tional controls. Existing major regulations affecting your device can may be subject to back as a sublema, 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 i lease of actived that I Drivination that your device complies with other requirements of the Act that I Dri has Intact a statutes and regulations administered by other Federal agencies. You must or any I 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 forth in the quarty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Steve A. Kahn

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wifi anon. The FDA finding of substantial equivalence of your device to a legally prematicated predicated on "The 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 in you desire specific as noliance at [phone]. Also, please note the regulation entitled, Connact the Office of Coach to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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 vours,

Mark A. Milkersen

Celia M. Witten, Ph.D., M.D. 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 Ko4d3d5 510(k) Number (if known) Device Name: Trochanteric Nail System

## Indications for Use

The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femures and I he Trochanteric Nan System is intention to tractures, high subtrochanteric fractures and including perfrochlanteric nactures, interactions is additionally indicated to treat combinations of these fractures. The Trochanterio Bong Fractures in osteoporotic bone of
pertrochanteric fractures associated with shaft fractures, pathologic fractures in os pertrochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, the dochanterio and chaptif son and malunions and revision procedures.

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)

Mark A. Millican

Division Sign-G Division of General, Restorative, and Neurological Devices

510(19 Number K092325

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