AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW

K141228 · Advanced Orthopaedic Solutions, Inc. · HSB · Jul 8, 2014 · Orthopedic

Device Facts

• Record ID: K141228
• Device Name: AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
• Applicant: Advanced Orthopaedic Solutions, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Jul 8, 2014
• 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 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

The AOS 6.5mm Fully Threaded Cancellous Screw is an internal fixation component designed for use with the AOS Antegrade Femoral Nail System. The screw is used in both recon and antegrade configurations; it can be threaded into and locked to the nail to provide stability for femoral fractures. The system is used by orthopedic surgeons in a clinical or surgical setting to stabilize bone fractures, facilitate healing, and manage conditions such as nonunions or pathologic fractures. By providing rigid internal fixation, the device helps restore structural integrity to the femur, potentially improving patient mobility and recovery outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological similarities to predicate devices.

Technological Characteristics

6.5mm diameter fully threaded cancellous screw; designed for integration with the AOS Antegrade Femoral Nail System; allows for locking to the nail; metallic internal fixation hardware.

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/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 Antegrade Femoral Nail System (K123569)
• DePuy ACE Universal and Troch Entry Femoral Nail Systems (K033329)
• I.T.S. GMBH IM Nail Systems CFN-CTN-CHN (K132945)

Submission Summary (Full Text)

{0}------------------------------------------------

JUL 0 0 2014

K141228 Page 1/2

!

Image /page/0/Picture/2 description: The image shows the letters "AOS" in a stylized font. The "A" is black, the "O" is black, and the "S" is black. The letters are bold and sans-serif. The "A" is slightly tilted to the left, and the "S" is slightly tilted to the right.

:

:

.

ADVANCED ORTHOPAEDIC SOLUTIONS

| <b>5. TRADITIONAL 510(K) SUMMARY</b> | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | July 1, 2014 |
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc.<br>3203 Kashiwa Street<br>Torrance, CA 90505<br>Phone: [phone] |
| CONTACT PERSON: | Anna Hwang<br>Advanced Orthopaedic Solutions, Inc.<br>3203 Kashiwa Street<br>Torrance, CA 90505<br>Phone: [phone] |
| DEVICE NAME: | AOS 6.5mm Captured, Fully Threaded Cancellous<br>Screw |
| COMMON NAME: | Internal Fixation |
| CLASSIFICATION: | Class II, 21 CFR 888.3020, Intramedullary Fixation<br>Rod |
| DEVICE CODE: | HSB |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | AOS Antegrade Femoral Nail System (510(k):<br>K123569, Cleared May 24, 2013); DePuy ACE<br>Universal and Troch Entry Femoral Nail Systems<br>(510(k): K033329, Cleared November 14, 2003); and<br>I.T.S. GMBH IM Nail Systems CFN-CTN-CHN<br>(510(k): K132945, Cleared March 7, 2014) |
| DEVICE DESCRIPTION: | The AOS 6.5mm Fully Threaded Cancellous Screw is<br>used in the AOS Antegrade Femoral Nail System, in<br>conjunction with the AOS Antegrade Femoral Nail.<br>The screw can be used in both recon and antegrade<br>configurations and can be threaded in and locked to<br>the nail. |
| INDICATIONS FOR USE: | The AOS Antegrade Femoral Nail is intended for use<br>in intramedullary fixation of fractures of the femur to<br>include the following: Open and closed femoral<br>fractures; pseudoarthrosis and correction osteotomy;<br>pathologic fractures, impending pathologic fractures,<br>and tumor resections; supracondylar fractures, |

:

{1}------------------------------------------------

## K141228

#### Page 2/2

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.

# SUBSTANTIAL EQUIVALENCE:

ﺎ

Information presented supports substantial equivalence of the AOS 6.5mm Fully Threaded Cancellous Screw to the predicate devices. The proposed system has the same indications for use, is similar in shape and design, and has the same fundamental technology.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Citx)9 Silver Spring, MD 20993-0002

July 8, 2014

Advanced Orthopaedic Solutions. Incorporated Ms. Anna Hwang 3203 Kashiwa Street Torrance. California 90505

Rc: K141228

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: May 7, 2014 Received: May 12, 2014

Dear Ms. Hwang:

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 frability 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

{3}------------------------------------------------

#### Page 2 - Ms. Anna Hwang

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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins

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

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for "AOS ADVANCED ORTHOPAEDIC SOLUTIONS". The letters "AOS" are in large, bold, black font. Below the letters is the text "ADVANCED ORTHOPAEDIC SOLUTIONS" in a smaller, bold, black font.

### 4. INDICATIONS FOR USE STATEMENT

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

510(k) Number (if known): K141228

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 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
- 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)

(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

Page 1/1

Page 4-1