(92 days)
No
The device description and performance studies focus on the mechanical properties and structural integrity of the bone plate system, with no mention of AI or ML technologies.
No.
The device is an internal fixation system used for long bone fracture fixation (tibia and femur), which is a treatment rather than a diagnostic or therapeutic function in itself.
No.
Explanation: The device is an internal fixation device for treating bone fractures, not for diagnosing medical conditions.
No
The device description clearly states it is an internal fixation device consisting of plates and screws, which are physical hardware components. The performance studies also focus on mechanical testing of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "long bone fracture fixation," specifically for treating fractures, non-unions, malunions, and osteotomies in the tibia and femur. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as an "internal fixation device" consisting of plates and screws. These are implants used to stabilize bones, not reagents or instruments used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used to physically fix bone fractures.
N/A
Intended Use / Indications for Use
The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:
- Diapyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
- . Non-unions and malunions
- Normal and osteopenic bone .
- Osteotomies .
Product codes
87 HRS, 87 HWC
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System is an internal fixation device that consists of monoaxial plates and various types of screws to fit different types of fractures in the tibia and femur. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 95-415mm in length and the screws will range from 10-150mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia and femur (long bones)
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
Non-clinical laboratory testing was performed for the AxSOS 3 Ti Locking Plate System components to determine substantial equivalence. Testing demonstrated that the AxSOS 3 Ti Locking Plate System is substantially equivalent to devices currently cleared for marketing. The following testing was performed: Static strength, Dynamic Fatigue Testing, Shear-Off Testing, Insertion Testing, Pull-Out Testing. Clinical testing was not required for this submission.
Key Metrics
Not Found
Predicate Device(s)
K061012/K122308 AxSOS Plus Locking Plate System, K062564 Synthes LCP Distal Femur Plates, K052390 Synthes LCP Proximal Tibia Plates, K972323 Osteo BOS System, K012162 Stryker Plating System Basic Fragment Set
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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| K123964 | |||
|---|---|---|---|
| 510(k) Summary | Page 1 of 2 | ||
| Proprietary Name: | AxSOS 3 Ti Locking Plate System | ||
| Common Name: | Bone plates | ||
| Bone Screws | MAR 2 8 2013 | ||
| Classification Name and Reference: | Single/multiple component metallic bone fixation | ||
| appliances and accessories 21 CFR §888.3030 | |||
| Smooth or threaded metallic bone fixation fastener | |||
| 21 CFR §888.3040 | |||
| Regulatory Class: | Class II | ||
| Product Codes: | 87 HRS: Plate, Fixation, Bone | ||
| 87 HWC : Screw, Fixation, Bone | |||
| Sponsor: | Stryker Trauma AG | ||
| Bohnackerweg 1 | |||
| CH-2545 Selzach | |||
| Switzerland | |||
| Contact Person: | Estela Celi | ||
| Regulatory Affairs Specialist | |||
| 325 Corporate Drive | |||
| Mahwah, NJ 07430 | |||
| Phone: (201) 831-6461 Fax: (201) 831-3461 | |||
| estela.celi@stryker.com | |||
| Date Prepared: | December 21, 2012 |
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System is an internal fixation device that consists of monoaxial plates and various types of screws to fit different types of fractures in the tibia and femur. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 95-415mm in length and the screws will range from 10-150mm in length.
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Intended Use
K123964
The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Page 2 of 2
Indications
The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:
- Diapyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
- Non-unions and malunions ●
- � Normal and osteopenic bone
- Osteotomies .
Summary of Technologies
Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices:
- . K061012/K122308 AxSOS Plus Locking Plate System
- K062564 Synthes LCP Distal Femur Plates .
- K052390 Synthes LCP Proximal Tibia Plates .
- K972323 Osteo BOS System .
- K012162 Stryker Plating System Basic Fragment Set .
Non-Clinical Testing
Non-clinical laboratory testing was performed for the AxSOS 3 Ti Locking Plate System components to determine substantial equivalence. Testing demonstrated that the AxSOS 3 Ti Locking Plate System is substantially equivalent to devices currently cleared for marketing.
The following testing was performed:
- . Static strength
- ◆ Dynamic Fatigue Testing
- Shear-Off Testing .
- Insertion Testing �
- Pull-Out Testing
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The AxSOS 3 Ti Locking Plate System is substantially equivalent to the predicate devices identified in this premarket notification.
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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 eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
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
Letter dated: March 28, 2013
Stryker Trauma AG % Ms. Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430
Re: K123964 Trade/Device Name: AxSOS 3 Ti Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: March 6, 2013 ﺒﻬﺎ. Received: March 7, 2013
Dear Ms. Celi:
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
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Page 2 -- Ms. Estela Celi
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/CDRH0ffices/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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Indications for Use
510(k) Number (if known): __________________
Device Name: AxSOS 3 Ti Locking Plate System
Indications for Use:
The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:
- Diapyseal, 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.研rank -S
Division of Orthopedic Devices
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