(75 days)
No
The summary describes a system of screws and instrumentation for internal bone fixation. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies are focused on mechanical testing of the components.
Yes
The device is used for internal bone fixation and fracture treatment, which directly addresses medical conditions to improve health.
No
Explanation: The Stryker VariAx 2 System is an internal bone fixation device used for internal fracture fixation, osteotomies, and revision procedures. Its function is to fix bones, not to diagnose medical conditions or diseases.
No
The device description explicitly states it consists of "screws and instrumentation," which are physical hardware components for internal bone fixation.
Based on the provided information, the Stryker VariAx 2 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "internal bone fixation in adult patients" and describes the surgical application of screws and plates to treat fractures and perform osteotomies and revision procedures. This is a direct medical intervention on the patient's body.
- Device Description: The device is described as an "internal fixation device consisting of screws and instrumentation." These are physical implants and surgical tools.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the mechanical properties of the screws and their ability to withstand forces (pull-out, shear-off, bending, fatigue). This is consistent with evaluating the structural integrity of an implantable device, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The Stryker VariAx 2 System is a surgical implant and associated instrumentation used for physical repair of bone.
N/A
Intended Use / Indications for Use
The Stryker VariAx 2 System is intended for internal bone fixation in adult patients.
The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:
- Internal fracture fixation; .
- Osteotomies: .
- Revision procedures such as non-unions or mal-unions; .
In addition, the following indications are specific to the devices listed below:
- . T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of:
- Compression fractures: O
- O Intra-articular and extra-articular fractures;
- Displaced fractures; o
- Reconstruction procedures; O
- . T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, O
- Displaced and compression fractures of the Distal Radius; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
- Reconstruction procedures in the Foot & Ankle and Distal Radius; o
- T 10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and . Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; O
- Single, segmental and comminuted fractures; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
- Normal bone density or osteopenic bone. 0
Product codes
HRS, HWC, HTN
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the VariAx 2 System. The VariAx 2 System is an internal fixation device consisting of screws and instrumentation that will be used in conjunction with previously cleared VariAx Plating Systems to treat a number of different types of fractures in the radius, ulna, humerus, clavicle, foot, and fibula. These screws can be used in conjunction with said plating systems, or in the case of non-locking screws, may also be used independently using a lag screw technique. The subject components will be available sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Radius, Ulna, Humerus, Clavicle, Foot, Fibula, Distal Radius, fore, mid and hind Foot and Ankle, Distal Humerus, Proximal Ulna, Distal Tibia
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 Testing:
- Screw Pull-Out Testing
- Screw Shear-Off Testing
- Screw Insertion Torque Testing
- Static Cantilever Bending of Locking Mechanism
- Dynamic Fatigue Plate-Screw Construct Testing.
Testing demonstrated that the VariAx 2 System is substantially equivalent to the predicate devices currently cleared for marketing.
Clinical Testing:
Clinical testing was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080667, K100271, K063875, K081284, K102282, K073527, K101056, K113760, K130009, K000636
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.
0
510(k) Summary
Proprietary Name: VariAx 2 System
Common Name: 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:
Sponsor:
Contact Person:
HRS: Plate, Fixation, Bone HWC: Screw, Fixation, Bone HTN: Washer, Bolt Nut
Stryker Trauma AG Bohnackerweg 1 CH-2545 Selzach Switzerland
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:
August 7, 2013
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the VariAx 2 System. The VariAx 2 System is an internal fixation device consisting of screws and instrumentation that will be used in conjunction with previously cleared VariAx Plating Systems to treat a number of different types of fractures in the radius, ulna, humerus, clavicle, foot, and fibula. These screws can be used in conjunction with said plating systems, or in the case of non-locking screws, may also be used independently using a lag screw technique. The subject components will be available sterile and non-sterile.
1
Intended Use
The Stryker VariAx 2 System is intended for internal bone fixation in adult patients.
Indications
The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:
- Internal fracture fixation; .
- Osteotomies: .
- Revision procedures such as non-unions or mal-unions; .
In addition, the following indications are specific to the devices listed below:
- . T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of:
- Compression fractures: O
- O Intra-articular and extra-articular fractures;
- Displaced fractures; o
- Reconstruction procedures; O
- . T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, O
- Displaced and compression fractures of the Distal Radius; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
- Reconstruction procedures in the Foot & Ankle and Distal Radius; o
- T 10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and . Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; O
- Single, segmental and comminuted fractures; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o
- Normal bone density or osteopenic bone. 0
2
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:
Table 1: Predicate devices
| 510(k) Number | |
|---|---|
| K080667 | VariAx Distal Radius Torx Screws |
| K100271 | VariAx Distal Radius Line Extension of XXL Plates |
| K063875 | Stryker Foot Plating System |
| K081284 | VariAx Distal Fibula Plate |
| K102282 | VariAx Locked Plating System Line Extension for Addition |
| of Fibula Straight Plates | |
| K073527 | VariAx Elbow System |
| K101056 | VariAx Elbow System |
| K113760 | VariAx Clavicle System |
| K130009 | VariAx 2 Compression Plating System |
| K000636 | Stryker Trauma Plating System |
Non-Clinical Testing
Non-clinical laboratory testing was performed for the VariAx 2 System components to determine substantial equivalence. Testing demonstrated that the VariAx 2 System is substantially equivalent to the predicate devices currently cleared for marketing.
The following testing was performed
- . Screw Pull-Out Testing
- Screw Shear-Off Testing .
- . Screw Insertion Torque Testing
- . Static Cantilever Bending of Locking Mechanism
- . Dynamic Fatigue Plate-Screw Construct Testing
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The VariAx 2 System is substantially equivalent to the predicate devices identified in this premarket notification.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2013
Stryker Trauma AG Mr. Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K132502
Trade/Device Name: VariAX 2 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, HTN Dated: August 7, 2013 Received: August 9, 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. 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
4
Page 2 - Mr. Elijah N. Wreh
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/4/Picture/7 description: The image shows the name "Erin Meith" in a stylized font. The letters are bold and black, with a unique design that makes them stand out. The name is likely a logo or a personal branding element. The font choice adds a modern and artistic touch to the name.
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _ K132502
Device Name: VariAx 2 System
Indications for Use:
The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:
- Internal fracture fixation: ●
- . Osteotomies;
- Revision procedures such as non-unions or mal-unions; ●
In addition, the following indications are specific to the devices listed below:
- T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the . Distal Radius, in the treatment of:
- Compression fractures; O
- Intra-articular and extra-articular fractures; 0
- Displaced fractures; 0
- Reconstruction procedures; 0
- � T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, midand hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, O
- Displaced and compression fractures of the Distal Radius; 0
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; 0
- o Reconstruction procedures in the Foot & Ankle and Distal Radius:
- T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and o Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna: 0
- 0 Single, segmental and comminuted fractures;
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle: 0
- Normal bone density or osteopenic bone. o
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices