ANTEGRADE FEMORAL NAIL

K123569 · Advanced Orthopaedic Solutions, Inc. · HSB · May 24, 2013 · Orthopedic

Device Facts

• Record ID: K123569
• Device Name: ANTEGRADE FEMORAL NAIL
• Applicant: Advanced Orthopaedic Solutions, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: May 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AOS Antegrade 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 intra articular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and maluions, fractures resulting from osteoprorosis.

Device Story

AOS Antegrade Femoral Nail System consists of titanium alloy rods, screws, and end caps for intramedullary fixation of femoral fractures. Device used by orthopedic surgeons in clinical/surgical settings to stabilize bone fractures. System provides mechanical support to bone segments to facilitate healing. Benefit includes stabilization of complex fractures, including those associated with tumors, osteoporosis, or previous joint replacements. No software or electronic components involved.

Clinical Evidence

No clinical data. Evidence consists of bench testing (mechanical testing per ASTM F384, in vitro testing of accessories) and a cadaver study to assess anatomical fit.

Technological Characteristics

Titanium alloy rods, screws, and end caps. Mechanical fixation via intramedullary rod. Testing performed per ASTM F384. No software, electronics, or energy sources.

Indications for Use

Indicated for patients requiring intramedullary fixation of femoral fractures, including open/closed fractures, pseudoarthrosis, correction osteotomy, pathologic/impending pathologic fractures, tumor resections, supracondylar fractures (with comminution/intra-articular extension), ipsilateral femur fractures, bone lengthening, periprosthetic fractures (proximal to TKA or distal to hip), nonunions, malunions, and osteoporotic 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 System (K012190)

Submission Summary (Full Text)

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#### VANCED ORTHOPAEDIC SOLUTIONS

## MAY 2 4 2018

#### 5. TRADITIONAL 510(K) SUMMARY

DATE PREPARED:

May 23, 2013

SUBMITTED BY:

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

CONTACT PERSON:

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

AOS Antegrade Femoral Nail System

COMMON NAME:

DEVICE NAME:

CLASSIFICATION:

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICE:

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

Internal Fixation

Class II, 21 CFR 888.3020 Intramedullary Fixation Rod

нав

AOS Modular Femoral System (510(k): K012190, Cleared September 24, 2001)

The AOS Antegrade Femoral Nail System consists of Titanium Alloy Rods, Screws and End Caps for femur fracture fixation.

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

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#### SUBSTANTIAL EQUIVALENCE:

Information presented supports substantial equivalence of the AOS Antegrade Femoral Nail System to the predicate device. 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 Antegrade Femoral Nail System was subjected to comparative mechanical testing per a test based on ASTM F384, as well as In Vitro testing of the accessory screws and components. A cadaver study was also done to assess various anatomical elements of the system. The results demonstrate that the AOS Antegrade Femoral Nails and accessories are substantially equivalent to the predicates.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### May 24, 2013

Advanced Orthopaedic Solutions, Incorporated % Ms. Julie Glendrange Regulatory Specialist 386 Beech Avenue, Unit B6 Torrance, California 90501

Re: K123569

Trade/Device Name: AOS Antegrade Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 23, 2013 Received: April 26, 2013

Dear Ms. Glendrange:

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. Please note: CDRH does 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Ms. Julie Glendrange

forth in the quality systems (OS) 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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

# Erin DKeith

For

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, sans-serif font. The "A" is stylized with a white outline, while the "O" and "S" are solid black. Below the logo, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are printed in a smaller, sans-serif font.

#### 7. INDICATIONS FOR USE STATEMENT

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

510(k) Number (if known): _ K123569

#### Device Name: AOS Antegrade Femoral Nail System

#### Indications for Use:

The AOS Antegrade 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 turnor resections .
- Supracondylar 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

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/21 description: The image shows a logo or letterhead with the name "Cassie L. Hanley, Ph.D." at the top. Below the name, it says "Division of Orthopedic Devices". There are some graphic elements above and to the right of the text, but they are not clearly identifiable.