SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES

K070294 · Synthes (Usa) · HSB · Mar 1, 2007 · Orthopedic

Device Facts

• Record ID: K070294
• Device Name: SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
• Applicant: Synthes (Usa)
• Product Code: HSB · Orthopedic
• Decision Date: Mar 1, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

Device Story

The Synthes TFN System is an orthopedic fixation device consisting of a cannulated femoral nail, a cannulated helical blade, and a cannulated nail end cap. This submission introduces additional lengths (75 mm, 125 mm, 130 mm) for the helical blade component. The system is used by surgeons in an operating room setting to stabilize fractures of the proximal femur. The device is implanted to provide internal fixation, facilitating bone healing and restoring structural integrity to the femur. It is intended for prescription use only.

Technological Characteristics

Cannulated femoral nail, helical blade, and end cap system. Materials and design are identical to the predicate TFN system. Intramedullary fixation rod (21 CFR 888.3020).

Indications for Use

Indicated for patients with stable and unstable proximal femur fractures, including pertrochanteric, intertrochanteric, and basal neck fractures. Long TFN indicated for subtrochanteric fractures, shaft-associated pertrochanteric fractures, pathologic fractures (prophylactic use), non-unions, malunions, and revisions.

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

• Synthes Trochanteric Fixation Nail (TFN) System

Submission Summary (Full Text)

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Ko70294

MAR 0 1 2007

| 3.0 | 510(k) Summary | | Page 1 of 1 |
|-----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | Sponsor: | Synthes (USA)<br>130 Goshen Parkway<br>West Chester, PA 19380<br>[phone] | |
| | Device Name: | Synthes Trochanteric Fixation Nail (TFN) System, additional<br>Helical Blades | |
| | Classification: | 21 CFR 888.3020: Rod, Fixation, Intramedullary and Accessories | |
| | Predicate Devices: | Synthes Trochanteric Fixation Nail (TFN) System | |
| | Device Description: | Synthes TFN System consists of a cannulated femoral nail, a<br>cannulated helical blade and a cannulated nail end cap. Synthes<br>Helical Blades will be available in three additional lengths, 75 mm,<br>125 mm, and 130 mm. | |
| | Intended Use: | Synthes Trochanteric Fixation Nail (TFN) System is intended to<br>treat stable and unstable fractures of the proximal femur including<br>pertrochanteric fractures, intertrochanteric fractures, basal neck<br>fractures, and combinations thereof. The Long TFN is additionally<br>indicated for subtrochanteric fractures, pertrochanteric fractures<br>associated with shaft fractures, pathologic fractures (including<br>prophylactic use) in both trochanteric and diaphyseal regions, long<br>subtrochanteric fractures, proximal or distal non-unions,<br>malunions, and revisions. | |
| | Substantial<br>Equivalence: | Information presented supports substantial equivalence. | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synthes (USA) % Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

MAR C 1 2007

Re: K070294

> Trade/Device Name: Synthes Trochanteric Fixation Nail (TFN) system, additional helical blades Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: January 30, 2007 Received: January 31, 2007

Dear Ms. Musgnung:

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

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Page 2 - Ms. Sheri L. Musgnung

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. 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" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark Al-Mulla

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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K070294
page 1 of

2.0

Indications for Use

702

Helical Blades

revisions.

510(k) Number (if known):

Device Name:

Indications for Use:

Mark H. Millikan

(Division Sign-Off Division of General, Restorative, and Neurological Devices

**510(k) Number**

K070394

X Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Synthes Trochanteric Fixation Nail (TFN) System, Additional

Synthes Trochanteric Fixation Nail (TFN) System is intended to

treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN

is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and

No

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)