TRIGEN STRAIGHT HUMERAL NAIL SYSTEM

K032722 · Smith & Nephew, Inc. · HSB · Oct 1, 2003 · Orthopedic

Device Facts

• Record ID: K032722
• Device Name: TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Oct 1, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only.

Device Story

Intramedullary nail system for surgical fixation of humeral fractures. Device implanted by orthopedic surgeons in clinical/OR settings to stabilize bone segments. Provides mechanical support to withstand in vivo loading. Single-use device.

Clinical Evidence

Bench testing only. Mechanical test data indicates the system is equivalent to devices currently used clinically and capable of withstanding expected in vivo loading.

Technological Characteristics

Intramedullary fixation rod (21 CFR 888.3020). Design features and material composition are consistent with predicate intramedullary nail systems.

Indications for Use

Indicated for patients with proximal and/or diaphyseal humeral fractures, non-unions, malalignments, pathological humeral fractures, or impending pathological humeral 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)
• Smith & Nephew's Intramedullary Nail System (K983942)
• Acumed's Polarus nails (K951740)

Submission Summary (Full Text)

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OCT - 1 2003

Ko327da
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# Smith & Nephew, Inc. Summary of Safety and Effectiveness TriGen Straight Humeral Nail System

## Contact Person and Address

Date of Summary: September 2, 2003

Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 [phone]

Name of Device: TriGen Straight Humeral Nail System Common Name: Intramedullary Nail

## Device Classification Name

21 CFR 888.3020 Intramedullary Fixation Rod - Class II

### Indications for Use

The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only.

#### Mechanical and Clinical Data

A review of the mechanical test data indicated that the TriGen Straight Humeral Nail System 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 Straight Humeral Nail System 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), Smith & Nephew's Intramedullary Nail System (K983942), and Acumed's Polarus nails (K951740).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wing, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT = 1 2003

Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. 1450 East Brooks Road Memphis, Tennessee 38116

Re: K032722

Trade/Device Name: TriGen Straight Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Inrtramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 2, 2003 Received: September 4, 2003

Dear Ms. Akil:

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. Janet Johnson Akil

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 yours,

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 Straight Humeral Nail System Indications Statement

The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only.

Marli N. Mellema

Restorative and Neuro 510(k) Number -

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use