(71 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for intramedullary fixation of various femoral fractures, which is a therapeutic intervention aimed at treating and stabilizing bone injuries.
No
The device is a femoral nail system used for the fixation of bone fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of "Titanium Allov Rods. Screws and End Caps," which are physical hardware components, not software.
No, 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 directly on the patient's body.
- Device Description: The device is described as Titanium Alloy Rods, Screws and End Caps. These are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The information provided describes a surgical implant used for orthopedic procedures, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The AOS Retrograde 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.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The AOS Retrograde Femoral Nail System consists of Titanium Allov 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 Retrograde Femoral Nail System was subjected to comparative mechanical testing per a test based on ASTM F384. The results demonstrate that the AOS Retrograde 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
ANCED ORTHOPAEDIC SQLUTIONS
5. TRADITIONAL 510(K) SUMMARY
Internal Fixation
Rod
HSB
DATE PREPARED:
September 3, 2013
SUBMITTED BY:
Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: (310) 533-9966
CONTACT PERSON:
Allyson Parks Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance. CA 90501 Phone: (310) 533-9966
AOS Retrograde Femoral Nail System
DEVICE NAME:
COMMON NAME:
CLASSIFICATION:
DEVICE CODE:
SUBSTANTIALLY EQUIVALENT DEVICE:
DEVICE DESCRIPTION:
INDICATIONS FOR USE:
AOS Modular Femoral Nail System (510(k): K012190, Cleared September 24, 2001), Stryker T2 Supracondylar Nail System (510(k): K023267, Cleared December 11, 2002), and AOS Antegrade Femoral Nail System (510(k): K123569, Cleared May 24, 2013)
Class II, 21 CFR 888.3020 Intramedullary Fixation
The AOS Retrograde Femoral Nail System consists of Titanium Allov Rods. Screws and End Caps for femur fracture fixation.
The AOS Retrograde 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
SEP 10 2013
Page 5-1
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joint, nonunions and malunions, and fractures resulting from osteoporosis.
SUBSTANTIAL EQUIVALENCE: Information presented supports substantial equivalence of the AOS Retrograde Femoral Nail System to the predicate devices. 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 Retrograde Femoral Nail System was subjected to comparative mechanical testing per a test based on ASTM F384. The results demonstrate that the AOS Retrograde Femoral Nails and accessories are substantially equivalent to the predicates.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
September 10, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOod-G609 Silver Spring, MD 20993-0002
Advanced Orthopaedic Solutions. Incorporation Ms. Allyson Parks Regulatory Associate 386 Beech Avenue, Unit B6 Torrance, California 90501
Re: K132005
Trade/Device Name: AOS Retrograde Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 02, 2013 Reccived: July 03, 2013
Dear Ms. Parks:
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 10 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 docs 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-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Allyson Parks
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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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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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, 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.
4. INDICATIONS FOR USE STATEMENT
Traditional 510(k) Premarket Notification Indication for Use Statement AOS Retrograde Femoral Nail System
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AOS Retrograde Femoral Nail System
Indications for Use:
The AQS Retrograde 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 .
- Supracondyiar 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 .
AND/OR Prescription Use: X (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
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