(87 days)
No
The summary describes a mechanical fixation system (plates, screws, washers, instruments) and its mechanical and MR performance testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device, VariAx 2 Mini Fragment System and VariAx 2 System, is used for fracture fixation, stabilization, reduction, and other restorative procedures involving bones, which are therapeutic interventions.
No
The detailed description of the VariAx 2 System indicates it is used for internal fixation (fracture fixation, reconstruction, etc.) and is composed of plates, screws, washers, and instruments. This points to a therapeutic or surgical device, not a device used to diagnose medical conditions.
No
The device description explicitly states it is composed of sterile and nonsterile plates, screws, washers, and instruments, which are hardware components.
Based on the provided text, 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 VariAx 2 Mini Fragment System and VariAx 2 System are described as devices for internal fixation of bones. They are composed of plates, screws, washers, and instruments that are surgically implanted into the body to stabilize fractures and perform other orthopedic procedures.
- Intended Use: The intended use clearly states fracture fixation, replantation, stabilization, reduction, fusions, osteotomies, mal-unions, etc., all of which are surgical procedures performed directly on the patient's body.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information about a patient's condition based on laboratory tests.
The device is a surgical implant and associated instruments, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
VariAx 2 Mini Fragment System:
The VariAx 2 Mini Fragment System is indicated for fracture fixation, replantation, stabilization, reduction, fusions, osteotomies, mal-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 - 21 years) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
VariAx 2 System:
The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:
- Fracture fixation, including single, segmental, and comminuted fractures
- Revision, including nonunion and malunion
- Intra- and extra-articular fractures
- Compression fracture
- Displaced fracture
- Reconstruction
- Replantation
- Arthrodesis
- Osteotomy
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS
Device Description
The VariAx 2 Mini Fragment System is used for internal fixations and is composed of sterile and nonsterile plates. Additionally, the plates are provided in locking and non-locking options, as well as various lengths, thicknesses, and configurations.
The VariAx 2 System is used for internal fixation applications and is composed of sterile and nonsterile screws, washers, and instruments. In addition to independent use, screws of this system are also used with compatible, internal fixation systems. These devices are made of commercially pure titanium and titanium alloy with Type III anodization, and are available in a variety of sizes and diameters, as well as locking and non-locking types.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones and small bone fragments; long bones (for non-load bearing stabilization and reduction); intra- and extra-articular fractures.
Indicated Patient Age Range
Adult and adolescent (12 - 21 years) patients for VariAx 2 Mini Fragment System.
Adult and pediatric patients (where the implant would not cross open growth plates) for VariAx 2 System.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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:
Comparative mechanical testing to the predicate system demonstrated substantial equivalence. The following tests were performed:
- Torsion
- Insertion Torque
- Pull-out
- Four-point bending
The aforementioned testing demonstrated that the VariAx 2 Mini Fragment System and the VariAx 2 System are substantially equivalent to the predicate devices. Additionally, MR assessments of magnetically-induced displacement force, magnetically-induced torque, RF-induced heating, and image artifacts demonstrate that the VariAx 2 Mini Fragment System and the VariAx 2 System are MR conditional.
Clinical Testing:
This submission does not require clinical testing.
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.
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
August 23, 2019
Stryker GmbH Sanja Jahr Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K191412
Trade/Device Name: VariAx 2 System, VariAx 2 Mini Fragment System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: May 24, 2019 Received: May 28, 2019
Dear Sanja Jahr:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali. MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
List of Cleared Devices in K191412
2
List of Cleared Devices in K191412
-
- VariAx 2 Mini Fragment System
-
- VariAx 2 System
3
Indications for Use
510(k) Number (if known) K191412
Device Name VariAx 2 Mini Fragment System
Indications for Use (Describe)
The VariAx 2 Mini Fragment System is indicated for fracture fixation, replantation, stabilization, reduction, fusions, osteotomies, mal-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 - 21 years) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known)
K191412
Device Name VariAx 2 System
Indications for Use (Describe)
The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:
- · Fracture fixation, including single, segmental, and comminuted fractures
- · Revision, including nonunion and malunion
- · Intra- and extra-articular fractures
- · Compression fracture
- Displaced fracture
- · Reconstruction
- · Replantation
- Arthrodesis
- · Osteotomy
| Type of Use (Select one or both, as applicable) | |
|---|---|
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
| Proprietary Name: | VariAx 2 Mini Fragment System |
|---|---|
| VariAx 2 System | |
| Common Name: | Bone screw |
| Bone plate | |
| Regulation Description: | Single/multiple component metallic bone fixation appliances |
| and accessories. | |
| Smooth or threaded metallic bone fixation fastener. | |
| Regulation Number: | 21 CFR 888.3030 |
| 21 CFR 888.3040 | |
| Product Code: | HRS |
| HWC | |
| Device Class: | Class II |
| Sponsor: | Stryker GmbH |
| Bohnackerweg l | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Sanja Jahr |
| Senior Regulatory Affairs Specialist | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: 201-831-6797 | |
| Fax: 201-831-6020 | |
| Date Prepared: | May 24, 2019 |
| Predicate Device: | VariAx 2 Mini Fragment System |
| Primary Predicate: Smith & Nephew Variable-Angle Locking | |
| Mini-Fragment Plating System (K132886) | |
| Reference Device: Synthes (USA) Modular Mini Fragment LCP | |
| System (K063049) | |
| VariAx 2 System | |
| Primary Predicate: VariAx 2 System (180500) | |
510(k) Summary
6
Description
The VariAx 2 Mini Fragment System is used for internal fixations and is composed of sterile and nonsterile plates. Additionally, the plates are provided in locking and non-locking options, as well as various lengths, thicknesses, and configurations.
The VariAx 2 System is used for internal fixation applications and is composed of sterile and nonsterile screws, washers, and instruments. In addition to independent use, screws of this system are also used with compatible, internal fixation systems. These devices are made of commercially pure titanium and titanium alloy with Type III anodization, and are available in a variety of sizes and diameters, as well as locking and non-locking types.
Indications for Use
VariAx 2 Mini Fragment System
The VariAx 2 Mini Fragment System is indicated for fracture fixation, replantation, stabilization, reduction, fusions, osteotomies, mal-unions, and non-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 – 21 years) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
VariAx 2 System
The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:
- · Fracture fixation, including single, segmental, and comminuted fractures
- · Revision, including nonunion and malunion
- Intra- and extra-articular fractures
- · Compression fracture
- Displaced fracture
- · Reconstruction
- · Replantation
- · Arthrodesis
- Osteotomy
Summary of Technologies
A comparison of the systems demonstrated that the VariAx 2 Mini Fragment System and the VariAx 2 System are substantially equivalent to the previously cleared Synthes (USA) Modular Mini Fragment LCP System (K063049), Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (K132886), and VariAx 2 System (K180500) in regard to intended use, material, design, and operational principles.
Non-Clinical Testing
Comparative mechanical testing to the predicate system demonstrated substantial equivalence. The following tests were performed:
- Torsion
7
VariAx 2 Mini Fragment System & VariAx 2 System Stryker GmbH
- . Insertion Torque
- . Pull-out
- . Four-point bending
The aforementioned testing demonstrated that the VariAx 2 Mini Fragment System and the VariAx 2 System are substantially equivalent to the predicate devices. Additionally, MR assessments of magnetically-induced displacement force, magnetically-induced torque, RF-induced heating, and image artifacts demonstrate that the VariAx 2 Mini Fragment System and the VariAx 2 System are MR conditional.
Clinical Testing
This submission does not require clinical testing.
Conclusion
The VariAx 2 Mini Fragment System and the VariAx 2 System described in this submission have the same indications, intended use, target patient population, technological characteristics, and materials as the predicate devices. The mechanical testing demonstrates the performance of the proposed devices is equivalent to the predicate devices.