(79 days)
No
The 510(k) summary describes a mechanical internal fixation system and does not mention any AI or ML components or functionalities.
No.
The device is an internal fixation system for fractures, not a therapeutic device designed to treat or prevent diseases.
No
Explanation: The device is an internal fixation system for bones, used for treatment (fixing fractures), not for diagnosing conditions.
No
The device description clearly states it is an "internal fixation device that consists of various plates used with compatible screws," indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Stryker VariAx 2 Compression Plating System is described as an "internal fixation device" consisting of plates and screws used to fix bones. This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for "internal fixation of bones," which is a surgical procedure, not a diagnostic test.
The information provided clearly indicates this is a device used within the body for structural support, not a device used to perform tests outside the body on biological samples.
N/A
Intended Use / Indications for Use
The Stryker VariAx 2 Compression Plating System is intended for internal fixation of bones in adult patients.
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:
- osteotomies, mal-unions, and non-unions
- single, segmental, and comminuted fractures .
- normal bone density and osteopenic bone
Product codes
HRS, HWC
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new VariAx 2 Compression Plating System. The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula
Indicated Patient Age Range
adult patients
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)
Non-clinical laboratory testing was performed for the VariAx 2 Compression Plating System components to determine substantial equivalence. Testing demonstrated that the VariAx 2 Compression Plating System is substantially equivalent to the predicate device currently cleared for marketing.
The following testing was performed
Dynamic Fatigue Testing .
Clinical testing was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K130009 Page 1/2 ·
510(k) Summary
MAR 2 2 2013
Proprietary Name: VariAx 2 Compression Plating System Common Name: Bone plates Bone Screws 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 87 HRS: Plate, Fixation, Bone Product Codes: 87 HWC : Screw, Fixation, Bone Stryker Trauma AG Sponsor: Bohnackerweg 1 CH-2545 Selzach Switzerland Contact Person: Estela Celi Regulatory Affairs Specialist
Date Prepared:
December 29, 2012
325 Corporate Drive Mahwah, NJ 07430
Phone: (201) 831-6461 Fax: (201) 831-3461
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new VariAx 2 Compression Plating System. The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.
1
Intended Use
The Stryker VariAx 2 Compression Plating System is intended for internal fixation of bones in adult patients.
Indications
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:
- osteotomies, mal-unions, and non-unions t
- single, segmental, and comminuted fractures .
- . normal bone density and osteopenic bone
Summary of Technologies
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the following predicate device:
- . K000684 Small Fragment Dynamic Compression Locking (DCL) System
- K082807- SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS
Non-Clinical Testing
Non-clinical laboratory testing was performed for the VariAx 2 Compression Plating System components to determine substantial equivalence. Testing demonstrated that the VariAx 2 Compression Plating System is substantially equivalent to the predicate device currently cleared for marketing.
The following testing was performed
Dynamic Fatigue Testing .
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The VariAx 2 Compression Plating System is substantially equivalent to the predicate device identified in this premarket notification.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2013
Stryker Trauma AG % Ms. Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K130009
Trade/Device Name: VariAx 2 Compression Plating 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, HWC Dated: January 18, 2013 Received: January 24, 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.
Erin DKeith
Mark N. Melkerson -Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _K130009
Device Name: VariAx 2 Compression Plating System
Indications for Use:
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:
- osteotomies, mal-unions, and non-unions .
- single, segmental, and comminuted fractures .
- normal bone density and osteopenic bone · ●
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)
Elizabet 标签Frank -S
Division of Orthopedic Devices