ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM

K042440 · Alphatec/Nexmed · HSB · Oct 7, 2004 · Orthopedic

Device Facts

• Record ID: K042440
• Device Name: ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM
• Applicant: Alphatec/Nexmed
• Product Code: HSB · Orthopedic
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alphatec Femoral Trochanteric Nail (FTN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures.

Device Story

The Femoral Trochanteric Nail (FTN) System is an orthopedic implant for fracture fixation. It consists of an intramedullary nail, lag screw, and distal static or dynamic screws; optional proximal cap screw. Implants are available in diameters of 10, 12, or 14 mm with nail angles of 130° or 135°. The device is used by orthopedic surgeons in a clinical/surgical setting to stabilize proximal femur fractures. The surgeon inserts the nail into the femoral canal to provide mechanical support and alignment for bone healing. The system is designed to restore structural integrity to the femur, facilitating patient recovery and mobility.

Clinical Evidence

Bench testing only. Mechanical and dynamic testing was performed to evaluate the performance of the FTN System compared to predicate devices.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI). Components: Intramedullary nail, lag screw, distal screws, proximal cap screw. Diameters: 10, 12, 14 mm. Angles: 130°, 135°. Mechanical fixation principle.

Indications for Use

Indicated for patients with stable or unstable proximal femur fractures, including pertrochanteric, intertrochanteric, and high subtrochanteric fractures, or combinations thereof.

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

• Trochanteric Nail (K010780)
• Trochanteric Nail (K021008)
• Trochanteric Dyax™ Nail System (K013524)

Submission Summary (Full Text)

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# Femoral Trochanteric Nail (FTN) System 510(k) SUMMARY September 2004

Koczydo

Alphatec Manufacturing, Inc. OC1 7 - 2004 -Company: 6110 Corte Del Cedro Carlsbad, CA 92009, USA [phone]

#### Ellen Yarnall, Director of Regulatory Affairs II. Contact Person:

#### Femoral Trochanteric Nail (FTN) System III. Trade/Proprietary Name:

### IV. Product Description:

The Femoral Trochanteric Nail (FTN) System consists of an intrameduliary nail, lag screw.
The reviron The Fenoral Trochanterio Nail (11), Syondistal static or dynamic screws. The proximal cap Sciew, Optonal and routers offered in diameters of 10, 12, or 14 mm. The diameter is 10 min with disar diamotors one for a lag screw and one for an anti-rolational proximal portion of the nairing the now of 135°, 130° or 135°. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI).

### V. Intended Use:

The Femoral Trochanteric Nail (FTN) System is intended to treat stable and unstable rne i chorar rroomantone han (ficluding pertrochanteric fractures, intertrochanteric proximal lidettres or chanteric fractures and combinations of these fractures.

# VI. Substantial Equivalence:

The FTN System is substantially equivalent to the following predicate devices:

| Trade/Proprietary Name | Manufacturer | Clearance |
|--------------------------------|---------------------|-----------|
| Trochanteric Nail | Depuy Orthopedics | K010780 |
| Trochanteric Nail | AOS | K021008 |
| Trochanteric Dyax™ Nail System | Howmedica Osteonics | K013524 |

# VI. Performance Data:

Mechanical and dynamic testing of the Alphatec FTN System was performed. The test Mcchanical and dyname the mechanical performance of the Alphatec FTN is at least comparable to, if not better than those of the predicate devices.

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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 a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2004

Ms. Ellen A. Yarnall Director of Regulatory Affairs Alphatec Manufacturing, Inc. 6110 Corte Del Cedro Carlsbad, California 92009

Re: K042440

Trade/Device Name: Femoral Trochanteric Nail (FTN) System Regulation Number: 21CFR 888. 3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 8, 2004 Received: September 9, 2004

Dear Ms. Yarnall:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) pening 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 enclosure) to regars actment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, are exactions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). alle Cosment Act (71ct) that do not requent of the general controls provisions of the Act. The I ou may, mercrore, manel alle act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is elabilitional controls. Existing major regulations affecting your device can may be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouv ocements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan I TCase oc advised that I DT 3 loseanse evour device complies with other requirements of the Act that 11971 has made a word regulations administered by other Federal agencies. You must or any I caeral statutes and regeraments, including, but not limited to: registration and listing (21 Comply with an the Not 270 care mans 201); good manufacturing practice requirements as set OF IC Fat 607); adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant of brovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Ellen A. Yarnall

This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to ocgin harketing your acrial equivalence of your device to a legally premarket nothcation. The PDA midning of backandal or 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 Patt 801), please of If you desire specific advice ion your ac not the can and and and the regulation entitled, conlact the Office of Compullios as (210) = i Ecation" (21CFR Part 807.97). You may obtain "Misbranding by relevelec to premance notifical via act from the Division of Small other general Information on your responsion.com as and its toll-free number [phone] or Manufacturers, International and Octosanters http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

C. Mark N. Milkerson

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

510(k) Number (if known): 042440_

Femoral Trochanteric Nail (FTN) System________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Prescription Use

2

(Part 21 CFR 801 Subpart D)

The Alphatec Femoral Trochanteric Nail (FTN) System is intended to treat stable and The Alphotoo Pentoral Troomative femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-On)
Division of General, Restorative,
and Neurological Devices

510(k) Number. K042440

000013

AND/OR

Over-The Counter Use

(21 CFR 801 Subpart C)