AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON

K141912 · Advanced Orthopaedic Solutions, Inc. · KTT · Oct 29, 2014 · Orthopedic

Device Facts

• Record ID: K141912
• Device Name: AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
• Applicant: Advanced Orthopaedic Solutions, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Oct 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AOS Small External Fixation System is intended to be used with the AOS External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where soft tissue injury may preclude the use of other fracture treatments. The AOS Small External Fixation System is intended to be non-weight bearing.

Device Story

Modular external fixation system for stabilization of bone fractures and reconstructive orthopedic surgery; comprises carbon fiber rods, titanium/stainless steel clamps, stainless steel threaded pins, and k-wires. Used in clinical settings by surgeons to manage fractures where soft tissue injury prevents internal fixation. System provides rigid frame construction via pin-to-rod and multi-pin clamps. Non-weight bearing. Benefits patient by providing stable fracture reduction and support during healing process.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Modular external fixation system. Materials: titanium and stainless steel clamps, stainless steel threaded pins (2.0mm/3.0mm) and k-wires (1.5mm), carbon fiber connector rods (5.0mm diameter). Mechanical fixation via clamps and pins. Non-sterile, single-use. Manual instrumentation includes wrenches and drill guides.

Indications for Use

Indicated for stabilization of open and/or unstable fractures of the hand, wrist, forearm, foot, and ankle where soft tissue injury precludes other treatments. Intended for non-weight bearing use.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• AOS External Fixation System (K080408)
• Stryker Hoffmann II Compact External Fixation System (K971755)
• Hoffmann Fixation Pin System (K861766)
• Hoffmann II Micro External Fixation System (K042019)
• DePuy Synthes Small External Fixation System (K122455)

Submission Summary (Full Text)

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

October 29, 2014

Advanced Orthopaedic Solutions, Incorporated Anna Hwang Regulatory Associate 3203 Kashiwa Street Torrance. California 90505

Re: K141912 Trade/Device Name: AOS Small External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: September 12, 2014 Received: September 16, 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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (21 CFR 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 -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K141912

Device Name AOS Small External Fixation System

#### Indications for Use (Describe)

The AOS Small External Fixation System is intended to be used with the AOS External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where soft tissue injury may preclude the use of other fracture treatments.

The AOS Small External Fixation System is intended to be non-weight bearing.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in blue, the "O" in blue, and the "S" in gray. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The text is black.

# 5. TRADITIONAL 510(K) SUMMARY

| DATE PREPARED: | September 8, 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 Small External Fixation System |
| COMMON NAME: | External Fixation |
| CLASSIFICATION: | Class II, 21 CFR 888.3030, Single/Multiple component<br>Metallic Bone Fixation Appliance and Accessories |
| DEVICE CODE: | KTT; JDW |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | AOS External Fixation System (510(k): K080408, Cleared<br>April 25, 2008); Stryker Hoffmann II Compact External<br>Fixation System and Hoffmann Fixation Pin System<br>(510(k): K971755/K861766, Cleared July 17, 1997 and<br>July 08, 1986); Hoffmann II Micro External Fixation<br>System, K042019(Cleared September 24, 2004); DePuy<br>Synthes Small External Fixation System (510(k): K122455,<br>Cleared April 11, 2013) |
| DEVICE DESCRIPTION: | The AOS Small External Fixation System is an external<br>fixation device comprised of rods, clamps, and threaded<br>pins used for the management of bone fractures and<br>reconstructive orthopedic surgery. The system is a<br>modular system designed to provide options in frame<br>construction, simplicity in frame components, and ease of<br>use. The AOS Small External Fixation System is<br>manufactured with threaded half pins and rods of 5.0mm<br>shaft diameter, which allows for connectivity with AOS'<br>External Fixation System (510(k) cleared: K080408) for<br>support with bone fractures. The system is comprised of<br>titanium and stainless steel (pin-to-rod and multi-pin)<br>clamps, stainless steel threaded half pins and k-wires,<br>carbon fiber connector rods, and pin caps. The AOS Small |

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External Fixation System is a non-sterile single use fixation device.

The pin-to-rod clamps are designed to clamp to the 5.0mm carbon fiber rods and to the 2.0mm and 3.0mm stainless steel pins. The multi-pin clamps are designed to stabilize fractures using multiple pins in close proximity to each other. The multi-pin clamps can be used individually or as part of a larger construct.

The stainless steel threaded pins come in thread diameters of 2.0mm and 3.0mm with a 5.0mm shaft diameter. Thread lengths are available in 5mm increments from 10mm to 25mm long. Overall pin lengths of 55mm, 75mm, 100mm and 140mm are available. The stainless steel k-wires are provided in a 1.5mm diameter.

The connecting rods are carbon fiber composite with an diameter of 5.0mm and are in lengths of 50mm, 75mm, 100mm, 125mm, 150mm, 200mm, 250mm, and 300mm.

The surgical technique used for the AOS Small External Fixation System is a standard method used for external fixation and is the same as the technique used for the predicate devices. The instrumentation for the system consists of a wrench, two T-wrenches, a drill quide, and drills.

INDICATIONS FOR USE: The AOS Small External Fixation System is intended to be used with the AOS External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where the soft tissue injury may preclude the use of other fracture treatments. The AOS Small External Fixation System is intended to be non-weight bearing.

SUBSTANTIAL EQUIVALENCE: Information presented supports substantial equivalence of the AOS Small External Fixation System due to the similarity in indication for use, design features, operating principles, and material of composition to the AOS External Fixation System, K080408; Stryker Hoffmann II Compact External Fixation System and Hoffmann Fixation Pin System K971755/K861766; Hoffmann II Micro External Fixation System, K042019; and DePuy Synthes Small External Fixation System, K122455.

> The construct of the AOS Small External Fixation System and the predicate devices are virtually identical. Since the devices are substantially equivalent in design, geometry, construction, materials of construction, and indications, it was determined that no mechanical testing was necessary to demonstrate substantial equivalence.