(36 days)
Not Found
No
The device description focuses on mechanical components (plates and screws) for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The performance studies are based on risk analysis and comparison to predicate devices, not on the performance metrics typically associated with AI/ML models.
No
The device is described as an internal fixation device for long bone fracture fixation, aligning with orthopedic surgery rather than therapeutic treatment.
No
The device is described as an "internal fixation device" for treating long bone fractures, non-unions, malunions, and osteotomies. Its function is to stabilize bones, not to diagnose conditions.
No
The device description explicitly states it is an internal fixation device consisting of plates and screws made from Titanium alloy, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for long bone fracture fixation." This describes a surgical implant used to stabilize broken bones within the body.
- Device Description: The description details "internal fixation device that consists of monoaxial locking plates and various types of screws." These are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on these in vitro tests.
Therefore, the AxSOS 3 Ti Locking Plate System Line Extension is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AxSOS 3 Ti Locking Plate System Line Extension is intended for long bone fracture fixation. Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
- Non-unions and malunions .
- Normal and osteopenic bone .
- . Osteotomies
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
This Special 510(k) submission is being supplied to the U.S. FDA to introduce additional screw types and drive features to the currently marketed AxSOS 3 Ti Locking Plate System (K123964). The additional screw types will include: 3.5mm and 4.5mm Cortex Shaft screws, 4mm and 6mm Cancellous partially and fully threaded screws. The subject device is an internal fixation device that consists of monoaxial locking plates and various types of screws to fit different types of fractures in the tibia and femur. The subject device consists of anatomically contoured Femur and Tibia plates and various types of screws which were previously cleared in K123964. All components are manufactured from Titanium alloy per ASTM F136. The Distal Lateral Femur plates are fixed to the femur using 5mm locking screws or non-locking screws with either or 4.5mm Cortex and 6mm cancellous non-locking screws. The Proximal Lateral Tibia plates are fixed to the tibia using 4mm locking screws with either or 3.5mm Cortex and 4mm cancellous non-locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone, tibia and 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)
A risk analysis was performed according to the requirements of ISO 14971: "Medical Devices -Application of risk management of medical devices." The evaluation demonstrated that the subject device did not present a new worst case and that the same verification and validation methods were applied to the subject components in comparison to the previously cleared predicate devices (K123964 & K972323). The analyses demonstrated that the subject components met the performance requirements and are as safe and effective as the predicate devices.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary
AxSOS 3 Ti Locking Plate System Line Extension
Proprietary Name:
Common Name:
Bone Screws
Classification Name and Reference: Smooth or threaded metallic bone fixation fastener 21 CFR §888.3040
Regulatory Class:
Class II
Product Codes:
Sponsor:
Stryker Trauma AG Bohnackerweg 1 CH-2545 Selzach Switzerland
87 HWC: Screw, Fixation, Bone
Contact Person:
Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah. NJ 07430 elijah.wreh@stryker.com Phone: 201-831-5691 Fax: 201-831-4691
Date Prepared:
November 8, 2013
Description
This Special 510(k) submission is being supplied to the U.S. FDA to introduce additional screw types and drive features to the currently marketed AxSOS 3 Ti Locking Plate System (K123964). The additional screw types will include: 3.5mm and 4.5mm Cortex Shaft screws, 4mm and 6mm Cancellous partially and fully threaded screws. The subject device is an internal fixation device that consists of monoaxial locking plates and various types of screws to fit different types of fractures in the tibia and femur. The subject device consists of anatomically contoured Femur and Tibia plates and various types of screws which were previously cleared in K123964. All components are manufactured from Titanium alloy per ASTM F136. The Distal Lateral Femur plates are fixed to the femur using 5mm locking screws or non-locking screws with either or
1
4.5mm Cortex and 6mm cancellous non-locking screws. The Proximal Lateral Tibia plates are fixed to the tibia using 4mm locking screws with either or 3.5mm Cortex and 4mm cancellous non-locking screws.
Intended Use
The AxSOS 3 Ti Locking Plate System Line Extension is intended for long bone fracture fixation.
Indications
The AxSOS 3 Ti Locking Plate System Line Extension is intended for long bone fracture fixation. Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
- Non-unions and malunions .
- Normal and osteopenic bone .
- . Osteotomies
Substantial Equivalency
The subject device components are substantially equivalent to the AxSOS 3 Ti Locking Plate System (K123964) and the Osteo BOS System (K972323, currently marketed as the Stryker Plating System) in regards to intended use, design, materials, and operational principles for use for long bone fracture fixation.
Non-Clinical Test
A risk analysis was performed according to the requirements of ISO 14971: "Medical Devices -Application of risk management of medical devices." The evaluation demonstrated that the subject device did not present a new worst case and that the same verification and validation methods were applied to the subject components in comparison to the previously cleared predicate devices (K123964 & K972323). The analyses demonstrated that the subject components met the performance requirements and are as safe and effective as the predicate devices.
Conclusion
The subject components of the AxSOS 3 Ti Locking Plate System Line Extension are substantially equivalent to the predicate devices identified throughout this submission.
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 eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2013
Stryker Trauma AG Mr. Elijah Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K133440
Trade/Device Name: AxSOS 3 Ti Locking Plate System (Line Extension) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 21, 2013 Received: November 22, 2013
Dear Mr. Wreh:
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 - Mr. Elijah Wreh
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 tolffree 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/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 yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K133440
Device Name: AxSOS 3 Ti Locking Plate System Line Extension
Indications for Use:
The AxSOS 3 Ti Locking Plate System Line Extension is intended for long bone fracture fixation.
Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
- Non-unions and malunions .
- Normal and osteopenic bone .
- . Osteotomies
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices