(258 days)
Not Found
No
The summary describes a mechanical orthopedic implant and its associated screws, with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device, a trochanteric nail system, is intended to treat various types of fractures of the femur, which is a therapeutic function.
No
This device is a trochanteric nail system used for fracture fixation, which is a treatment device, not a diagnostic one. Its purpose is to treat fractures, not to diagnose them.
No
The device description and performance studies clearly indicate this is a physical orthopedic implant (nail and screws) used for fracture fixation, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a trochanteric nail and screws) used to fix bone fractures in the femur. This is a device that is implanted into the body for a therapeutic purpose, not used to test samples outside the body.
The information provided focuses on the mechanical properties and surgical application of the device, which is consistent with a Class II or Class III medical device used for orthopedic surgery, not an IVD.
N/A
Intended Use / Indications for Use
The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for 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 nonunions and malunions and revisions procedures.
Product codes
HSB
Device Description
The AOS Solid Locking and Telescoping Lag Screws are used in the AOS Trochanteric Nail System, in conjunction with the AOS Trochanteric Nail. Both AOS screws can be locked to the nail. The Telescoping Lag Screw allows the threads to collapse within the barrel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, trochanteric and diaphyseal areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
The AOS Solid Locking and Telescoping Lag Screws were each subjected to static and fatigue testing in accordance with ASTM F384, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. The results demonstrate that the Solid Locking and Telescoping Lag Screws are substantially equivalent to the predicate devices. Additionally, the Telescoping Lag Screw was subjected to torque testing in accordance with ASTM F543, Standard Specifications and Test Methods for Metallic Medical Bone Screws.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AOS
ADVANCED ORTHOPAEDIC SOLUTIONS
PAGE 1 OF 2
5. TRADITIONAL 510(K) SUMMARY OCT 2 2012 DATE PREPARED: October 1, 2012 Advanced Orthopaedic Solutions, Inc. SUBMITTED BY: 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 DEVICE NAME: AOS Trochanteric Nail System, Telescoping (TC") Lag Screw and Solid Locking Lag Screw COMMON NAME: Internal Fixation CLASSIFICATION: Class II, 21 CFR 888.3020 Rod, Fixation, Intramedullary and Accessories DEVICE CODE: HSB SUBSTANTIALLY EQUIVALENT DEVICE: AOS Trochanteric Nail System (510(k): K021008, Cleared June 20, 2002 and K103533, Cleared Jan. 19, 2011); and EBI® Trochanteric Nail System (510(k): K050118, Cleared Feb. 16, 2005) DEVICE DESCRIPTION: The AOS Solid Locking and Telescoping Lag Screws are used in the AOS Trochanteric Nail System, in conjunction with the AOS Trochanteric Nail. Both AOS screws can be locked to the nail. The Telescoping Lag Screw allows the threads to collapse within the barrel. INDICATIONS FOR USE: The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic
1
use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal nonunions and malunions and revisions procedures.
1129 148
SUBSTANTIAL EQUIVALENCE: Information presented supports substantial equivalence of the AOS Solid Locking and Telescoping Lag Screws to the predicate devices. The proposed systems have the same indications for use, are similar in shape and design, have the same fundamental technology and are made of the same material.
PRECLINICAL TESTING: The AOS Solid Locking and Telescoping Lag Screws were each subjected to static and fatigue testing in accordance with ASTM F384, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. The results demonstrate that the Solid Locking and Telescoping Lag Screws are substantially equivalent to the predicate devices. Additionally, the Telescoping Lag Screw was subjected to torque testing in accordance with ASTM F543, Standard Specifications and Test Methods for Metallic Medical Bone Screws.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars representing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
OCT 2 2012
Advanced Orthopaedic Solutions, Inc. % Ms. Julie Glendrange 386 Beech Avenue, Unit B6 Torrance, CA 90501
Re: K120148
Trade/Device Name: Solid Locking Lag Screw and TCII - Telescoping Lag Screw Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 14, 2012 Received: September 17, 2012
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
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
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Page 2 – Ms. Julie Glendrange
device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Erin S. Keith
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative 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 letters "AOS" in a bold, sans-serif font. The letters are black, and the background is white. The letter "A" has a textured pattern on the left side. The letters are large and fill most of the frame.
VANCED ORTHOPAEDIC SOLUTIONS
4. INDICATIONS FOR USE STATEMENT
Traditional 510(k) Premarket Notification Indications for Use Statement AOS Trochanteric Nail System
510(k) Number (if known): K120148
Device Name: AOS Trochanteric Nail System
Indications for Use:
The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for 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.
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)
Ashif
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
K120148 510(k) Number .