(20 days)
Not Found
No
The 510(k) summary describes a mechanical intramedullary nail system for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities. The focus is on the physical properties and intended use of the device.
No.
The device is an intramedullary nail system for temporary fixation of tibial fractures, acting as a load-sharing device until the fracture heals, rather than directly providing therapy.
No
Explanation: The device, the AOS Tibial Nail System, is an intramedullary fixation device used for temporary stabilization of tibial fractures. Its purpose is to provide structural support and aid in the healing process of bone fractures, not to diagnose medical conditions or diseases.
No
The device description explicitly states it consists of titanium intramedullary nails, proximal and distal locking screws, and end caps, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary stabilization of various types of fractures, malunions, and nonunions of the tibia." This describes a surgical implant used to fix bones, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details "intramedullary fixation devices for the temporary fixation of various types of fractures of the tibia." This further reinforces its function as a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The AOS Tibial Nails are intramedullary fixation devices for the temporary fixation of various types of fractures of the tibia and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Tibial Nail System consists of titanium intramedullary nails, proximal and distal locking screws, and end caps.
This Special 510(k) proposes the addition of 12mm and 13mm diameter nails to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia
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)
physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed nails and the predicate nails.
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
K130625 page 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a bold, sans-serif font. Below the letters is the text "ADVANCED ORTHOPAEDIC SOLUTIONS" in a smaller, sans-serif font. The logo is simple and professional, and it conveys the company's focus on orthopaedics.
MAR 2 8 2013
8. SPECIAL 510(K) SUMMARY
March 7. 2013
HSB
SUMMARY PREPARED ON:
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 12mm and 13mm Tibial Nails
DEVICE NAME: COMMON NAME: CLASSIFICATION:
DEVICE CODE:
SUBSTANTIALLY EQUIVALENT DEVICE:
DEVICE DESCRIPTION:
AOS Tibial Nail System (K070444, June 14, 2007)
Rod, Fixation, Intramedullary and Accessories
Class II, 21 CFR 888.3020 Intramedullary fixation rod
The AOS Tibial Nails are intramedullary fixation devices for the temporary fixation of various types of fractures of the tibia and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Tibial Nail System consists of titanium intramedullary nails, proximal and distal locking screws, and end caps.
This Special 510(k) proposes the addition of 12mm and 13mm diameter nails to the system.
INDICATIONS FOR USE:
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.
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SUBSTANTIAL EQUIVALENCE:
Information presented supports substantial equivalence of the 12mm and 13mm Tibial Nails to the predicate device. The proposed nails have the same indications for use, are similar in geometry and design, have the same fundamental scientific technology, and are made of the same material (Ti-6Al-4V ELI, per ASTM F136) as the predicate nails. As detailed in the submission, the proposed nails do . not present a worst-case scenario with respect to strength characteristics, and because of their similarity to the current nails, physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed nails and the predicate nails.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Letter dated: March 28, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Orthopaedic Solutions, Incorporated % Ms. Allyson Parks Regulatory Associate 386 Beech Avenue, Unit B6 Torrance, California 90501
Re: K130625
Trade/Device Name: AOS 12mm and 13mm Tibial Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: March 7, 2013 Received: March 18, 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 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. Iisting 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. 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 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,
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, sans-serif font. Below the letters is the text "ADVANCED ORTHOPAEDIC SOLUTIONS" in a smaller, sans-serif font. The logo is simple and professional.
7. INDICATIONS FOR USE STATEMENT
Special 510(k) Premarket Notification Indication for Use Statement AOS 12mm and 13mm Tibial Nails
510(k) Number (if known): _K130625
Device Name: AOS 12mm and 13mm Tibial Nails
Indications for Use:
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.
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 Orthopaedic Devices
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