AOS Small Bone Nailing System

K163014 · Advanced Orthopaedic Solutions, Inc. (Aos) · HSB · Jan 24, 2017 · Orthopedic

Device Facts

• Record ID: K163014
• Device Name: AOS Small Bone Nailing System
• Applicant: Advanced Orthopaedic Solutions, Inc. (Aos)
• Product Code: HSB · Orthopedic
• Decision Date: Jan 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AOS Small Bone Nail System is intended for fixation of fractures and osteotomies of the fibula, radius and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.

Device Story

AOS Small Bone Nailing System consists of titanium alloy (Ti-6Al-4V) intramedullary nails (110mm-260mm length; 2.5mm-5.0mm diameter) and cortical locking screws (3.5mm and 2.7mm). Used by orthopedic surgeons for fracture fixation and osteotomies of the fibula, radius, and ulna. Implanted into the medullary canal to provide structural stability. System provides mechanical fixation to facilitate bone healing. Longer cortical screws offer increased bone engagement compared to predicates. Device is purely mechanical; no software or electronic components.

Clinical Evidence

No clinical data. Bench testing only. Comparative mechanical testing performed per ASTM F1264-14 (four-point bend test) demonstrated performance substantially equivalent to predicate devices.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V). Dimensions: 110mm-260mm length, 2.5mm-5.0mm diameter. Fixation: 2.7mm and 3.5mm cortical locking screws. Mechanical testing per ASTM F1264-14. No software or electronic components.

Indications for Use

Indicated for fixation of fractures and osteotomies of the fibula, radius, and ulna, particularly in cases with narrow medullary canals or where implant flexibility is required.

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

• Synthes Elastic Intramedullary Nail (EIN) (K971783)
• Acumed Small Bone Locking Rod System II (K031438)
• Acumed Small Bone IM Nail System (K143276)
• Smith & Nephew Intramedullary Nail System (K983942)

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

Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla Regulatory Affairs Manager 3203 Kashiwa St. Torrance, California 90505

January 24, 2017

Re: K163014

Trade/Device Name: AOS Small Bone Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 7, 2016 Received: October 28, 2016

Dear Alex Bhaskarla:

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 devicerelated adverse events) (21 CFR 803); 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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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,

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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |
| <b>Indications for Use</b> |

| Form Approved: OMB No. 0910-0120 |
|-----------------------------------|
| Expiration Date: January 31, 2017 |
| <i>See PRA Statement below.</i> |

| 510(k) Number (if known) | K163014 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | AOS Small Bone Nailing System |
| Indications for Use (Describe) | The AOS Small Bone Nail System is intended for fixation of fractures and osteotomies of the fibula, radius and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount. |

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <div> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |

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|----------------------------------------|-------------|
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Image /page/3/Picture/1 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 a dark teal color, the "O" in a light gray color, and the "S" in a dark teal color. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font.

## 6. TRADITIONAL 510(K) SUMMARY

| DATE PREPARED: | October 7, 2016 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc.<br>3203 Kashiwa Street<br>Torrance, CA 90505<br>Phone: [phone]<br>Establishment Registration #: 2032480<br>Owner Operator Number: 9046896 |
| CONTACT PERSON: | Alex Bhaskarla<br>Advanced Orthopaedic Solutions, Inc.<br>3203 Kashiwa Street<br>Torrance, CA 90505<br>Phone: [phone] |
| DEVICE NAME: | AOS Small Bone Nail System |
| COMMON NAME: | Intramedullary Fixation Rod/Pin |
| CLASSIFICATION: | Class II, 21 CFR 888.3020, Intramedullary Fixation<br>Rod/Pin |
| DEVICE CODE: | HSB |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | Synthes Elastic Intramedullary Nail (EIN) K971783<br>Acumed Small Bone Locking Rod System II K031438<br>Acumed Small Bone IM Nail System K143276<br>Smith & Nephew Intramedullary Nail System K983942 |
| DEVICE DESCRIPTION: | The AOS Small Bone Nail is a titanium alloy (Ti-6Al-<br>4V) intramedullary nail available in various lengths<br>(110mm to 260mm) and diameters (2.5mm to<br>5.0mm). The nail is compatible with use of 3.5mm<br>and 2.7mm cortical locking screws that allow for<br>additional fracture fixation and locking capabilities. |
| INDICATIONS FOR USE: | The AOS Small Bone Nail System is intended for<br>fixation of fractures and osteotomies of the fibula,<br>radius and ulna, including fractures where the<br>medullary canal is narrow or flexibility of the implant<br>is paramount. |

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| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantial equivalence of the AOS Small Bone Nail System 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. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BASIS FOR SUBSTANTIAL EQUIVALENCE: | The AOS Small Bone Nailing System has the |

AOS Small Bone Nailing System has the following similarities to the predicates:

- same device classification ●
- same lengths
- same material .
- same anatomical sites
- same intended use ●
- same biocompatibility
- same shaft diameter
- same locking screw diameters ●

The AOS Small Bone Nailing System has longer cortical screws. Longer screw lengths provide more engagement with the bone. Mechanically, the subject nail proved stronger than the predicate device used for testing.

- PRECLINICAL TESTING: The AOS Small Bone Nail System was subjected to comparative mechanical testing per a four point bend test based on ASTM F1264-14. The results demonstrate that the AOS Small Bone Nail are substantially equivalent to the predicates.
- STANDARDS: Recognized industry standards are cited in the Standards Report
- CLINICAL DATA: There is no clinical data referenced in this 510(k)

PERFORMANCE TESTING

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the AOS Small Bone Nail System was conducted in accordance with various international standards and internal AOS methods.