(135 days)
Not Found
No
The summary describes a mechanical implant (locking plate system) and its testing, with no mention of AI or ML.
No.
The device is described as a "locking plate system" intended for "fixation of long bone fractures," which suggests it is a device to stabilize a fracture, not one that actively treats or cures a disease or condition.
No
The device is a system for long bone fracture fixation, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a "Locking Plate System" and describes physical plates for bone fixation, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in long bone fracture fixation." This describes a surgical implant used to stabilize bone fractures.
- Device Description: The description details a "Locking Plate System" and "tibia long plates," which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The AxSOS Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not not limited to fractures of the humerus, tibia and femur.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
This Special 510(k) submission is a line extension to address modifications made to the AxSOS Locking Plate System which was cleared in K061012. This line extension is to add tibia long plates to the existing size range of the AxSOS Locking Plate System. These monoaxial long plates will be known as AxSOS Proximal Lateral Tibia Long Plates and will be available in four length sizes in left and right configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, tibia, 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)
Risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. Testing has been performed as per ASTM F382-99 to demonstrate equivalence of the subject device to its predicate device. Finite Element Analysis (FEA), was used to identify the worst case for plate loading. Static strength testing using axial compression was performed. Fatigue strength testing was conducted using axial loading. Results were used to evaluate median fatigue limits and dynamic stiffness, therefore substantiating equivalence to the comparative proximal lateral tibia plates of the Stryker Plating System cleared under K050512.
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
§ 888.3030 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.
0
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510(k) Summary AxSOS Locking Plate System
| Proprietary Name: | AxSOS Locking Plate System |
|---|---|
| Common Name: | Bone plates |
| Classification Name and Reference: | Single/multiple component metallic bone fixation |
| appliances and accessories, 21 CFR §888.3030 | |
| Regulatory Class: | Class II |
| Product Codes: | 87 HRS: Plate, Fixation, Bone |
| Predicate Devices: | AxSOS Locking Plate System |
| Stryker Plating System | |
| For Information contact: | John DeMauro, Regulatory Affairs Consultant |
| Stryke Trauma AG | |
| Bohnackerweg 1 | |
| CH-2545 Selzach | |
| Switzerland | |
| Phone: (201) 831-5804 Fax: (201) 831-4804 | |
| john.demauro@stryker.com | |
| Date Prepared: | November 2, 2012 |
Description
This Special 510(k) submission is a line extension to address modifications made to the AxSOS Locking Plate System which was cleared in K061012. This line extension is to add tibia long plates to the existing size range of the AxSOS Locking Plate System. These monoaxial long plates will be known as AxSOS Proximal Lateral Tibia Long Plates and will be available in four length sizes in left and right configurations.
Intended Use
The AxSOS Locking Plate System is intended for use in long bone fracture fixation.
Indications
The AxSOS Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
1
Substantial Equivalence
The AxSOS Proximal Lateral Tibia Long Plates are substantially equivalent to the AxSOS Proximal Lateral Tibia Plates of the AxSOS Locking Plate System cleared under K061012 and to the Proximal Lateral Tibia Plates of the Stryker Plating System (SPS) cleared under K050512 in regards to intended use, design, materials, and operational principles as a bone fixation device.
Summary of Non-Clinical Testing and Evaluation
Risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. Testing has been performed as per ASTM F382-99 to demonstrate equivalence of the subject device to its predicate device. Finite Element Analysis (FEA), was used to identify the worst case for plate loading. Static strength testing using axial compression was performed. Fatigue strength testing was conducted using axial loading. Results were used to evaluate median fatigue limits and dynamic stiffness, therefore substantiating equivalence to the comparative proximal lateral tibia plates of the Stryker Plating System cleared under K050512.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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
March 20, 2013
Stryker Trauma AG % Howmedica Osteonics Corporation Ms. Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430
Re: K123403
Trade/Device Name: AxSOS Proximal Lateral Tibia Long Plates 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 1, 2013 Received: March 4, 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, 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
3
Page 2 - Ms. Estela Celi
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.
Image /page/3/Picture/7 description: The image shows the name "Erin Keith" in a stylized font. The letters "E", "r", "i", and "n" are in a bold, sans-serif font. The letters "K", "e", "i", "t", and "h" are also in a bold font, but they are decorated with geometric shapes and lines. The overall effect is modern and eye-catching.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
K123403 Page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name: AxSOS Proximal Lateral Tibia Long Plates
Indications for Use:
The AxSOS Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
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)
Elizabethi LErank -S
Divison of Orthopedic Devices