(85 days)
Not Found
No
The 510(k) summary describes a mechanical internal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is an internal fixation system used to stabilize fractures, osteotomies, mal-unions, and non-unions, which are restorative functions, not therapeutic.
No
The device is described as an internal fixation device used for treating fractures and osteotomies, not for diagnosing medical conditions.
No
The device description clearly states it is an internal fixation device consisting of plates and screws, which are hardware components.
Based on the provided information, the Stryker VariAx 2 Compression Plating System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the VariAx 2 Compression Plating System is an "internal fixation device" used for "internal fixation of fractures" in various bones. This involves surgically implanting the device into the body to stabilize broken bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples outside the body, or providing diagnostic information based on such analysis.
Therefore, the Stryker VariAx 2 Compression Plating System is a surgical implant used for orthopedic fixation, not an IVD.
N/A
Intended Use / Indications for Use
The Stryker VariAx 2 Compression Plating System is 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:
- osteotomics, mal-unions, and non-unions .
- single, segmental, and comminuted fractures .
- normal bone density and osteopenic bone .
Product codes (comma separated list FDA assigned to the subject device)
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 modified VariAx 2 compression plate of the VariAx 2 Compression Plating System, previously cleared in K 130009. 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, 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 modified plates to determine substantial equivalence. Testing demonstrated that the modified plates are substantially equivalent to the previously cleared K 130009.
The following testing was performed
- Compression Plates Screw Through Compression Hole 0° and 15° Angulation with . VariAx Screws
Clinical testing was not required for this submission.
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
Page 1 of 2
K140565
510(k) Summary
| 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 |
| Product Codes: | 87 HRS: Plate, Fixation, Bone |
| 87 HWC: Screw, Fixation, Bone | |
| Sponsor: | Stryker Trauma AG |
Contact Person:
CH-2545 Selzach Switzerland 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:
March 3, 2014
Bohnackerweg l
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the modified VariAx 2 compression plate of the VariAx 2 Compression Plating System, previously cleared in K 130009. 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.
41
1
K140565
Intended Use
The Stryker VariAx 2 Compression Plating System is 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:
- osteotomics, mal-unions, and non-unions .
- 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:
- . K130009 VariAx 2 Compression Plating System .
Non-Clinical Testing
Non-clinical laboratory testing was performed for the VariAx 2 Compression Plating System modified plates to determine substantial equivalence. Testing demonstrated that the modified plates are substantially equivalent to the previously cleared K 130009.
The following testing was performed
- Compression Plates Screw Through Compression Hole 0° and 15° Angulation with . VariAx Screws
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 is a black and white logo. The logo features a stylized bird in flight, with three curved lines representing its wings and body. The bird is oriented towards the right. Encircling the bird is text that reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.
Food und Drug Administration 10903 New Hampshire Avenue Document Control Control - WO&G-Cib09 Silver Spring, MD 20993-0002
May 29, 2014
Stryker Trauma AG Ms. Estela Celi Sr. Specialist Regulatory Affairs 325 Corporate Drive Mahvah, New Jersey 07430
Re: K140565
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: March 3, 2014 Received: March 5, 2014
Dear Ms. Celi:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 9 rethy promotice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersuale commerce prior to May 28, 1976, the enactment date of the Medical Device American of God Days commerce provide in accordinate with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ion and Cosment Act (Act) that to not require approvate on the general controls provisions of the Act. The You may, therefore, mance the device, only of to me more registration, listing of general controls provisions of the revilabilions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contact librility addition. Please note: CDATT does not ovations must be truthful and not misleading.
If your device is classilied (see above) into cither class II (Special Controls) or classified on be If your device is classified (see above) into via regulations affecting your device and be may be subject to additional controls. "Internations. Title 21, Parts 800 to 898. In addition, FDA may found in the Code of Toderal Regoncerning your device in the Federal Register.
Please be advised that FDA `s issuance of a substantial equivalence determination dos not mean Please be advised that FDA s issuality of a substantiner with other requirements of the Act Inal IT/X has made a delemination that your correst by other Federal agencies. You must or any rederal statutes and regulations administed to: registration and listing comply with all the Act 3 requirements, moral device reporting (reporting of medical (2) CFR Part 807): labeling (21 CFR 803); good manufacturing practice requirements as scl
3
Page 2 - Ms. Estela Celi
forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/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 Industry and Consumer Education at its toll-frée number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
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): _K140565
Device Name: VariAx 2 Compression Plating System
Indications for Usc:
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:
1
- osteotomies, mal-unions, and non-unions .
- single, segmental, and comminuted fractures .
- normal bone density and osteopenic bone .
Over-The-Counter Use Prescription Use X AND/OR (2) CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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