(92 days)
No
The device description and intended use are solely focused on mechanical fixation of bone fractures using traditional intramedullary nails and associated hardware. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is described as an intramedullary fixation device for fractures of various long bones, including the femur, humerus, and tibia, which falls under the definition of a therapeutic device as it treats an injury or condition.
No
The provided text describes several "AOS Nails" which are "intramedullary fixation devices for the temporary fixation of various types of fractures of long bones." Their intended use is to treat fractures, not to diagnose them.
No
The device description explicitly states that the device consists of titanium intramedullary nails, proximal and distal locking screws, and end caps, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as an intramedullary fixation device for treating bone fractures in the femur, humerus, and tibia. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components of the device (nails, screws, end caps) used for bone fixation. This aligns with a surgical implant, not a diagnostic tool.
- Lack of IVD characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to physically stabilize bone fractures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HSB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, Humerus, Tibia
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
AOS Antegrade Femoral Nail (K123569, 5/24/13)
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.
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)
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
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:
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.
1
INDICATIONS FOR USE:
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.
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,
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the proposed nails only differ in sterilization method, which does not change the safety or effectiveness of . . . . the nails. .
3
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
4
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
5
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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