The AOS Antegrade and Retrograde Femoral Nail are 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 ioint, nonunions and malunions, fractures resulting from osteoporosis.

The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures. The Humeral Nail is also intended to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.

The AOS Tibial Nail System is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The AOS Tibial Nail System is indicated for long bone fracture fixation of tibial fractures, which may include the following: transverse, oblique, spiral, segmental and comminuted fractures; fractures with bone loss and bone transport; open and closed fractures, pathologic fractures; corrective osteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.

The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intentrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

Device Description

AOS Nails are intramedullary fixation devices for the temporary fixation of various types of fractures of long bones and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Nail Systems consist of titanium intramedullary nails, proximal and distal locking screws, and end caps.

This Special 510(k) proposes the addition of gamma terminally sterilized nails, screws, and end caps.

AI/ML Overview

This document describes a Special 510(k) premarket notification for AOS Intramedullary Nails, focusing on the addition of gamma terminally sterilized nails, screws, and end caps.

1. Table of Acceptance Criteria and the Reported Device Performance:

The provided text does not include explicit acceptance criteria or reported device performance data in the manner typically seen for performance studies of medical devices that generate quantitative results (e.g., sensitivity, specificity, accuracy for diagnostic devices, or specific mechanical thresholds for implants tested against an established standard).

Instead, the document asserts substantial equivalence to predicate devices. The basis for substantial equivalence is that "The proposed nails have the same indications for use, geometry and design, have the same fundamental scientific technology, and are made of the same material (Ti-6AI-4V ELI, per ASTM F136) as the predicate nails. As detailed in the submission, the proposed nails only differ in sterilization method, which does not change the safety or effectiveness of the nails."

Therefore, the "acceptance criteria" can be inferred as meeting the criteria for substantial equivalence, primarily demonstrating that the change in sterilization method does not alter safety or effectiveness. The "reported device performance" is the assertion of equivalence to predicate devices, implying that their performance characteristics are maintained.

Inferred Acceptance Criteria:

Maintenance of indications for use.
Maintenance of geometry and design.
Maintenance of fundamental scientific technology.
Maintenance of material (Ti-6AI-4V ELI, per ASTM F136).
Sterilization method (gamma terminal sterilization) does not negatively impact safety or effectiveness.

Reported Device Performance (based on substantial equivalence claim):

The device performs effectively for intramedullary fixation of various long bone fractures, aligning with the predicate devices.
Safety is maintained with the new sterilization method.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable (N/A). This submission is for a Special 510(k) based on substantial equivalence, not a performance study requiring a test set of data. The "test" is primarily a comparison against existing predicate devices and a justification that the change in sterilization does not alter performance.
Data Provenance: Not explicitly stated as there is no new performance study with a test set. The data provenance implicitly refers to the information and performance of the established predicate devices, which are already legally marketed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable (N/A). No test set requiring expert ground truth establishment for performance evaluation is mentioned in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable (N/A). No test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is an intramedullary nail, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone performance study was not done. This device is a surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable (N/A). No new performance study requiring ground truth is described. The "ground truth" for the device's efficacy and safety is derived from the established performance and regulatory clearance of the predicate devices.

8. The sample size for the training set:

Not applicable (N/A). This document does not describe a machine learning algorithm or a training set.

9. How the ground truth for the training set was established:

Not applicable (N/A). This document does not describe a machine learning algorithm or a training set.

Summary

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DEC 3 1 2013

8. SPECIAL 510(K) SUMMARY

SUMMARY PREPARED ON:

December 23, 2013

AOS Humeral Nails AOS Tibial Nails AOS Trochanteric Nails

HSB

SUBMITTED BY:

Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505 Phone: (310) 533-9966

CONTACT PERSON:

Kazunori Mivahara Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505 Phone: (310) 533-9966

AOS Antegrade and Retrograde Femoral Nails

Rod, Fixation, Intramedullary and Accessories Class II, 21 CFR 888.3020 Intramedullary fixation rod

DEVICE NAME:

COMMON NAME: CLASSIFICATION: DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICE:

AOS Antegrade Femoral Nail (K123569, 5/24/13) AOS Retrograde Femoral Nail (K132005, 9/10/13) AOS Humeral Nail (K050241, 3/14/05) AOS Proximal Humeral Nail (K090478, 3/26/09) AOS Tibial Nail (K070444, 6/14/07) AOS 12mm and 13mm Tibial Nails (K130625, 3/28/13) AOS Trochanteric Nail (K021008, 6/20/02) AOS ES Trochanteric Nail (K103533, 1/19/11) AOS Solid Locking and Telescoping Lag Screw (K120148, 10/2/12)

DEVICE DESCRIPTION:

This Special 510(k) proposes the addition of gamma terminally sterilized nails, screws, and end caps.

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INDICATIONS FOR USE:

SUBSTANTIAL EQUIVALENCE:

Information presented supports substantial equivalence of the AOS Nail Systems to the predicate devices. The proposed nails have the same indications for use, geometry and design, have the same fundamental scientific technology, and are made of the same material (Ti-6AI-4V ELI, per ASTM F136) as the predicate nails. As detailed in the submission,

Page 8-2

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the proposed nails only differ in sterilization method, which does not change the safety or effectiveness of . . . . the nails. .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Advanced Orthopaedic Solutions, Incorporated Attention: Kazunori Miyahara Product Development Engineer 386 Beech Avenue, Unit B6 Torrance, California 90501

Re: K133081

Trade/Device Name: AOS Intramedullary Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 4, 2013 Received: December 5, 2013

Dear Kazunori Miyahara:

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

December 31, 2013

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Page 2 - Kazunori Miyahara

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 (800) 638-2041 or (301) 796-7100 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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark Nemelkerson -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/5/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.

7. INDICATIONS FOR USE STATEMENT

Special 510(k) Premarket Notification Indication for Use Statement Intramedullary Nails

K133081 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: AOS Intramedullary Nail

Indications for Use:

The AOS Antegrade and Retrograde Fornoral Nall is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed fractures, Pseudoarthrosis and correction ostectorny, Pathologic fractures, impending pathologic fractures and turnor resections, Supracondition those with severe comminution and intra articular extension, lossiates, bone lengthening, fractures proximal to a total knee arthroplasty or prosinesis, fractures distal to a hip joint, nonunions, and fractures resulting from osteoporosis.

The ACS Humeral Nati is Intended to treat stable proximal frectures of the himmers including two and in some cases four part humeral Nail is also intended to treat proximal and distal one third fractures, midshaff fractures and pathological fractures.

The ACS Tibial Nail is Intended to provide temporary stabilization of various majurions, and nonunions of the this. The AOS Tibial Nail System is indication of Iblation of Iblal fractures, which may include the following: transvarse; oblique, spiral, segmental and comminuted fractures with bone toss and bone transont; open and closed fractures, pathologic fractures; corrective osteotomies; pseudantitirosis of the fibial shaft; nonumions. malunions, melaphyseal and epiphyseal fractures.

The AOS Trochanteric Nail is intended to treat stable proximal fractures of the femur including pertrochanteric. intertrocharteric and high subtrochanteric fractures and combinations of these fractures. The inn the additionally indicated for subtrochanteric fractures associated with shall fractures, pathologic fractures (including prochylacitc use) in osleoporolic bone of the trackanteric and diachysed areas, long subtrochanteric frasilated fornoral fractures, proximal and distal non-unions and malunions and revisions procedures.

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 )

Image /page/5/Figure/13 description: The image shows a logo with the text "Casey L. Hanley, Ph.D." on the top left. There is a horizontal line going across the middle of the image. Below the line, the text "Division of Orthopedic Devices" is present. The logo also includes a stylized graphic that appears to be part of the FDA logo.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
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.(b)
Classification. Class II.