RETROGRADE FEMORAL NAIL

K132005 · Advanced Orthopaedic Solutions, Inc. · HSB · Sep 10, 2013 · Orthopedic

Device Facts

• Record ID: K132005
• Device Name: RETROGRADE FEMORAL NAIL
• Applicant: Advanced Orthopaedic Solutions, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Sep 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AOS Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with severe comminution and intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis.

Device Story

AOS Retrograde Femoral Nail System consists of titanium alloy rods, screws, and end caps for intramedullary fixation of femoral fractures. Used by orthopedic surgeons in clinical/surgical settings to stabilize bone fractures. Device provides mechanical support to facilitate bone healing and alignment. Benefits include stabilization of complex fractures, including those associated with tumors, osteoporosis, or prior arthroplasty.

Clinical Evidence

Bench testing only. Comparative mechanical testing was performed based on ASTM F384 to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Materials: Titanium alloy. Principle: Intramedullary fixation rod. Form factor: Rods, screws, and end caps. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients with femoral fractures requiring intramedullary fixation, including open/closed fractures, pseudoarthrosis, correction osteotomy, pathologic/impending pathologic fractures, tumor resections, supracondylar fractures (with comminution/intraarticular extension), ipsilateral femur fractures, bone lengthening, fractures proximal to total knee arthroplasty/prosthesis, fractures distal to hip joint, nonunions, malunions, and osteoporosis-related 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

• AOS Modular Femoral Nail System (K012190)
• Stryker T2 Supracondylar Nail System (K023267)
• AOS Antegrade Femoral Nail System (K123569)

Submission Summary (Full Text)

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# ANCED ORTHOPAEDIC SQLUTIONS

### 5. TRADITIONAL 510(K) SUMMARY

Internal Fixation

Rod

HSB

DATE PREPARED:

September 3, 2013

SUBMITTED BY:

Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: [phone]

CONTACT PERSON:

Allyson Parks Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance. CA 90501 Phone: [phone]

AOS Retrograde Femoral Nail System

DEVICE NAME:

COMMON NAME:

CLASSIFICATION:

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICE:

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

AOS Modular Femoral Nail System (510(k): K012190, Cleared September 24, 2001), Stryker T2 Supracondylar Nail System (510(k): K023267, Cleared December 11, 2002), and AOS Antegrade Femoral Nail System (510(k): K123569, Cleared May 24, 2013)

Class II, 21 CFR 888.3020 Intramedullary Fixation

The AOS Retrograde Femoral Nail System consists of Titanium Allov Rods. Screws and End Caps for femur fracture fixation.

The AOS Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with severe comminution and intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip

SEP 10 2013

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joint, nonunions and malunions, and fractures resulting from osteoporosis.

SUBSTANTIAL EQUIVALENCE: Information presented supports substantial equivalence of the AOS Retrograde Femoral Nail System to the predicate devices. The proposed system has the same indications for use, is similar in shape and design, has the same fundamental technology and is made of the same material.

### PRECLINICAL TESTING:

The AOS Retrograde Femoral Nail System was subjected to comparative mechanical testing per a test based on ASTM F384. The results demonstrate that the AOS Retrograde Femoral Nails and accessories are substantially equivalent to the predicates.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

September 10, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOod-G609 Silver Spring, MD 20993-0002

Advanced Orthopaedic Solutions. Incorporation Ms. Allyson Parks Regulatory Associate 386 Beech Avenue, Unit B6 Torrance, California 90501

Re: K132005

Trade/Device Name: AOS Retrograde Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 02, 2013 Reccived: July 03, 2013

Dear Ms. Parks:

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 10 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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Allyson Parks

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default_htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Mark N. Melkerson - S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a bold, stylized font. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The text is all in black and the background is white.

### 4. INDICATIONS FOR USE STATEMENT

Traditional 510(k) Premarket Notification Indication for Use Statement AOS Retrograde Femoral Nail System

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

## Device Name: AOS Retrograde Femoral Nail System

### Indications for Use:

The AQS Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following:

- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Supracondyiar fractures, including those with severe comminution and . intraarticular extension
- lpsilateral femur fractures .
- Bone lengthening .
- Fractures proximal to a total knee arthroplasty or prosthesis �
- Fractures distal to a hip joint .
- Nonunions and malunions ●
- Fractures resulting from osteoporosis .

AND/OR Prescription Use: X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use: (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

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