LONG TROCHANTERIC NAIL SYSTEM

K013563 · DePuy Orthopaedics, Inc. · HSB · Dec 27, 2001 · Orthopedic

Device Facts

• Record ID: K013563
• Device Name: LONG TROCHANTERIC NAIL SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Dec 27, 2001
• Decision: SESE
• Submission Type: Traditional
• 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

Long Trochanteric Nail System; intramedullary fixation device for femur fractures. Components include intramedullary nail, lag screw, end cap, and optional anti-rotation screw. Manufactured from Titanium (Ti-6Al-4V ELI). Used by orthopedic surgeons in clinical/surgical settings to stabilize femoral fractures. Device provides mechanical support to bone segments to facilitate healing. Substantially equivalent to existing intramedullary nail systems.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to predicate devices.

Technological Characteristics

Intramedullary fixation rod; material: Titanium (Ti-6Al-4V ELI); components: nail, lag screw, end cap, anti-rotation screw. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients with stable/unstable proximal femoral fractures, including pertrochanteric, intertrochanteric, high subtrochanteric, and combined fractures. Also 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

• ACE Trochanteric Nail (K010780)
• ACE AIM Femoral Nail (K871539)
• Synthes Proximal Femoral Nail (K973240)
• Smith & Nephew TriGen Nail (K981529)

Submission Summary (Full Text)

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DEC 2 7 2001

K013563
page 1 of 2

# 510(k) Summary

| Name of Sponsor: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 510(k) Contact: | Marcia J. Arentz<br>Senior Regulatory Associate<br>Phone: [phone]<br>FAX: [phone] | |
| Trade Name: | Long 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: | Code: 87NDE or 87HSB<br>No performance standards have been established<br>under Section 514 of the Federal Food, Drug,<br>and Cosmetic Act for intramedullary nails. | |
| Substantially Equivalent Device: | ACE Trochanteric Nail<br>ACE AIM Femoral Nail<br>Synthes Proximal Femoral Nail<br>Smith & Nephew TriGen Nail | K010780<br>K871539<br>K973240<br>K981529 |
| Device Descriptions: | The Trochanteric Long Nail System consists of<br>an intramedullary nail, lag screw, end cap, and<br>optional anti-rotation screw, all manufactured<br>from Titanium (Ti-6Al-4V ELI) which are used<br>to treat fractures of the femur. | |

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KWI3563
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### 510(k) Summary (continued)

| Indications for use: | The Trochanteric Nail System is intended to treat<br>stable and unstable proximal fractures of the femur<br>including pertrochanteric fractures, intertrochanteric<br>fractures, high subtrochanteric fractures and<br>combinations of these fractures. The Trochanteric<br>Long Nail system is additionally indicated to treat<br>pertrochanteric fractures associated with shaft<br>fractures, pathologic fractures in osteoporotic bone<br>of the trochanteric and diaphyseal areas, long<br>subtrochanteric fractures, ipsilateral femoral<br>fractures, proximal or distal non-unions and<br>malunions and revision procedures. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial equivalence: | The Trochanteric Nail System has the same<br>intended use, is manufactured from the same<br>material and has the same design features as the<br>predicate devices and is therefore substantially<br>equivalent. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three flowing lines representing the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the figure in a circular pattern.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2001

Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K013563

Trade Name: Trochanteric Long Nail System Regulation Number: 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: October 21, 2001 Received: October 26, 2001

Dear Ms. Arentz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Marcia J. Arentz

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N. Melhemor

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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K013563
page 1 of 1

510(k) Number (if known):

Device Name: Long Trochanteric Nail System

#### Indications for Use:

The Trochanteric Nail System is intended to treat stable and unstable proximal fractures The frochanteric Nan Dystein is intenteric fractures, intertrochanteric fractures, high of the fremar fractures and combinations of these fractures. The Trochanteric Long Sublivenancere fractures and combinated to treat pertrochanteric fractures associated with Natt System is additionally marcures in osteoporotic bone of the trochanteric and shart fractures, paulonogro- nacteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.

Concurrence of CDRH, Office of Device Evaluation

for Mark A. Milliken

(Division :11) Division c everal, Restorative and and ogical Devices

K 01356 510(k) Number _

000003

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use