ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL

K021008 · Advanced Orthopaedic Solutions, Inc. · HSB · Jun 20, 2002 · Orthopedic

Device Facts

• Record ID: K021008
• Device Name: ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
• Applicant: Advanced Orthopaedic Solutions, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Jun 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, insilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

Device Story

AOS Trochanteric Nail is a cannulated intramedullary fixation rod designed for proximal femoral fracture stabilization. Device components include the nail, sliding lag screw, anti-rotation screws, and end cap. The nail is inserted through the greater trochanter. It features proximal diameters of 15mm, nail diameters of 9mm or 11mm, and lengths ranging from 18cm to 42cm. Proximal holes are angled at 125° or 130° with 10° anteversion in long nail configurations. Distal end includes cross-locking holes and slots for 5.0mm screws. Used by orthopedic surgeons in an operating room setting to provide internal fixation for femoral fractures, facilitating bone healing and patient mobility.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparison to legally marketed predicate devices.

Technological Characteristics

Cannulated intramedullary nail; materials not specified; proximal diameter 15mm; nail diameters 9mm and 11mm; lengths 18cm, 30cm, 36cm, 42cm; proximal holes angled 125° or 130°; 10° anteversion in long nails; distal cross-locking holes/slots for 5.0mm screws; mechanical fixation via lag screw and anti-rotation screws.

Indications for Use

Indicated for patients with stable or unstable proximal femoral fractures, including pertrochanteric, intertrochanteric, and high subtrochanteric fractures. Long nail version indicated for subtrochanteric fractures, 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

• DePuy ACE, Trochanteric Nails (K010780, K013563)
• Howmedica Osteonics, Gamma Nails (K993670, K012158, K013524)
• Smith and Nephew, Intramedullary Hip Screw (K912162, K921786, K954712)

Submission Summary (Full Text)

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# JUN 2 0 2002

### 510(k) SUMMARY

| NAME OF FIRM: | Advanced Orthopaedic Solutions |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT PERSON: | Paul Doner<br>Vice President Operations and Regulatory |
| TRADE NAME: | AOS Trochanteric Nail |
| COMMON NAME: | Intramedullary Fixation Rod |
| CLASSIFICATION: | 888.3020 Intramedullary Fixation Rod. |
| DEVICE CODE: | HSB |
| SUBSTANTIALLY EQUIVALENT DEVICE: | DePuy Ace, Trochanteric Nail & Long Trochanteric Nail;<br>Howmedica, Gamma Nail & Trochanteric Dyax Nail; Smith and<br>Nephew, Intramedullary Hip Screw |

### INTENDED USE:

The AOS Trochanteric Nail is intended to treat stable proximal fractures of the femur including pertrochanteric interic and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertochanteric fractures associated with shaft fractures pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, insilateral fractures, proximal and distal non-unions and malunions and revisions procedures.

#### DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:

The AOS Trochanteric Nail is femoral intramedullary nail that is design to enter through the greater trochanter. It consists of an intramedullary nail, sliding lag screw, anti-rotation screws and end cap.

The Trochanteric Nail is a cannulated nail with proximal diameter of 15mm. The short Trochanteric Nails are18cm in length and the long Trochanteric Nails are 30cm, 36cm and 42cm in length. The nails are produced in diameters of 9mm, and 11mm. The proximal end of the nail has two holes; one to accept the 11mm lag screw and one to accept the optional 5.0mm anti-rotation screw. There are two nail configurations with the proximal holes angled at 125° or 130°. The proximal holes in the long nails having 10° of anteversion and are in a left and a right configuration. The proximal end of the nail is threaded to accept an end can.

The distal end of the nail contains one cross locking hole and one cross locking slot. The distal hole and the slot are design to accept 5.0mm screws.

The AOS Trochanteric Nail was shown to be substantially equivalent to the following devices.

| DePuy ACE, Trochanteric Nails | K010780 and K013563 |
|--------------------------------------------|-------------------------------|
| Howmedica Osteonics, Gamma Nails | K993670, K012158 and K013524 |
| Smith and Nephew, Intramedullary Hip Screw | K 912162, K921786 and K954712 |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 0 2002

Mr. Paul Doner Vice President Operations and Regulatory Advanced Orthopaedic Solotions 333 W. 6th Street, Suite 202 San Pedro. CA 90731

Re: K021008

Trade/Device Name: Advanced Orthopaedic Solutions Trochanteric Nail Regulatory Number: 888.3020 Regulatory Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 27, 2002 Received: March 28, 2002

Dear Mr. Doner:

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 - Mr. Paul Doner

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 yours.

for Mark N Milliken

Celia 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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510(k) Number (if known)

Advanced Orthopaedic Solutions Trochanteric Nail Device Name:

KO21008

. Indications for Use:

The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, insilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

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Over-The-Counter
Mark N Miller

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

510(k) Number.