TRIGEN TROCHANTERIC ANTEGRADE NAIL

K040462 · Smith & Nephew, Inc. · HSB · Mar 23, 2004 · Orthopedic

Device Facts

• Record ID: K040462
• Device Name: TRIGEN TROCHANTERIC ANTEGRADE NAIL
• Applicant: Smith & Nephew, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Mar 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. Trochanteric Antegrade Nail is for single use only.

Device Story

TriGen Trochanteric Antegrade Nail is an intramedullary fixation rod; used for stabilization of long bone and femoral fractures. Device features proximal holes/slots for screws threading into femoral head; provides compression and rotational stability. Implanted by orthopedic surgeons in clinical/OR settings. Mechanical design allows for in vivo loading support during bone healing. Single-use device.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical test data indicates the device is equivalent to currently used clinical devices and capable of withstanding expected in vivo loading without failure.

Technological Characteristics

Intramedullary fixation rod; metallic construction (implied titanium based on predicate). Features proximal holes/slots for femoral head screws. Designed for internal fixation of long bone fractures.

Indications for Use

Indicated for patients with simple long bone fractures, comminuted/spiral/oblique/segmental fractures, nonunions, malunions, polytrauma, impending pathologic fractures, tumor resection/grafting, supracondylar fractures, and bone length adjustments. Specifically indicated for fractures between proximal and distal thirds of long bones. Proximal screw-hole variants indicated for subtrochanteric fractures with lesser trochanteric involvement, ipsilateral femoral shaft/neck fractures, and intertrochanteric fractures.

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

• Smith & Nephew's Titanium Nail System (K981529)
• Intramedullary Nail System (K983942)

Submission Summary (Full Text)

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## MAR 2 3 2004

K040462
page 1 of 1

Date of Summary: February 20, 2004

Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen Trochanteric Antegrade Nail

Contact Person and Address Kim Kelly Project Manager, Regulatory/Clinical Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 [phone]

Name of Device: TriGen Trochanteric Antegrade Nail Common Name: Intramedullary Nail

#### Device Classification Name

21 CFR 888.3020 Intramedullary fixation rod - Class II

#### Indications for Use

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. Trochanteric Antegrade Nail is for single use only.

### Mechanical and Clinical Data

A review of the mechanical test data indicated that the TriGen Trochanteric Antegrade Nail is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.

### Substantial Equivalence Information

The substantial equivalence of the TriGen Trochanteric Antegrade Nail is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices – Smith & Nephew's Titanium Nail System (K981529) and Intramedullary Nail System (K983942).

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized symbol that consists of three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2004

Ms. Kim Kelly Project Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116

Re: K040462

Trade/Device Name: TriGen Trochanteric Antegrade Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 20, 2004 Received: March 8, 2004

Dear Ms. Kelly:

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. Kim Kelly

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/dsma/dsmamain.html

Sincerely vours.

Mark M. Milliman

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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# TriGen Trochanteric Antegrade Nail Indications Statement

040462
page 1 of 1

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following turnor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. The Smith & Nephew, Inc. Trochanteric Antegrade Nail is for single use only.

Mark N Milkeon

Restorative,

**510(k) Number** K040462

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_