(185 days)
Not Found
No
The device description and intended use focus on mechanical fixation of bone fractures. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
This device is a therapeutic device because its intended use is for intramedullary fixation of various femoral fractures, which involves treating and correcting a medical condition.
No
The device is described as an "intramedullary fixation" system for fractures of the femur, indicating it is an orthopedic implant for treatment, not diagnosis. The "Intended Use" section explicitly states its purpose is for "fixation of fractures."
No
The device description explicitly states that the system consists of "Titanium Alloy Rods, Screws and End Caps," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the intramedullary fixation of fractures of the femur. This is a surgical procedure performed in vivo (within the living body) to stabilize broken bones.
- Device Description: The device consists of Titanium Alloy Rods, Screws and End Caps. These are implants designed to be surgically inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a physical condition directly within the body.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
нав, HSB
Device Description
The AOS Antegrade Femoral Nail System consists of Titanium Alloy Rods, Screws and End Caps for femur fracture fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for AOS. The logo consists of the letters "AOS" in a bold, sans-serif font. The "A" is partially outlined in white, while the "O" and "S" are solid black. Below the letters, there is some text that is not clearly visible.
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: (310) 533-9966
CONTACT PERSON:
Julie Glendrange Advanced Orthopaedic Solutions. Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: (310) 533-9966
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.
1
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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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