(60 days)
Not Found
No
The summary describes a traditional orthopedic implant system for calcaneus fractures, focusing on material properties, sterilization, and mechanical testing. There is no mention of AI/ML in the intended use, device description, or performance studies. The reference to the "SOMA database for the design of the plates" likely refers to anatomical data used in the design process, not an AI/ML algorithm within the device itself.
No.
The device is a non-active implant intended for temporary stabilization of bones or bone fragments, specifically for calcaneus fractures, which describes a structural support rather than a therapeutic treatment in itself.
No
The device is a non-active implant intended for temporary stabilization of bones or bone fragments, not for diagnosing conditions.
No
The device description explicitly states it is a "non-active implant(s)" and refers to "plates," indicating it is a physical hardware device intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fractures of the calcaneus," which is a structural issue with bone.
- Device Description: The device is described as a "non-active implant(s) intended to provide temporary stabilization for bones or bone fragments." This is a surgical implant, not a diagnostic tool.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such testing. IVDs are used in vitro (outside the body) to diagnose diseases or conditions.
- Performance Studies: The performance studies focus on mechanical testing (ASTM F382-17) and biocompatibility, which are relevant for surgical implants, not IVDs.
The device is a surgical implant used to treat a physical injury (fracture), not a diagnostic tool used to identify a disease or condition through testing of samples.
N/A
Intended Use / Indications for Use
Stryker VariAx 2 MIS Calcaneus is indicated for fractures of the calcaneus.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
This Traditional 510(k) submission is submitted to the U.S. FDA to provide authorization to market the VariAx 2 MIS Calcaneus plates. The goal of the Subject Device VariAx 2 MIS Calcaneus is to offer a comprehensive range of calcaneal implants and instruments in one system utilizing the VariAx 2 platform technology and SOMA database for the design of the plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calcaneus
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)
Non-Clinical Testing
- . The Subject Device(s) biocompatibility profile is equivalent to the previously cleared Reference Device(s) regarding material formulation, processing, sterilization, and geometry.
- The Subject Device sterilization methods and parameters remain the same as the Predicate Device.
- Verification testing (ASTM F382-17) was performed on the Subject Device and the acceptance criterion was fulfilled.
- MR compatibility testing was conducted on the Subject Device.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 8, 2022
Stryker GmbH Jonathan Schell Sr. Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K221346
Trade/Device Name: Stryker VariAx 2 MIS Calcaneus 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: May 6, 2022 Received: May 9, 2022
Dear Jonathan Schell:
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, M.P.H. 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
2
Indications for Use
510(k) Number (if known) K221346
Device Name VariAx 2 MIS Calcaneus
| Indications for Use (Describe) |
|---|
| Stryker VariAx 2 MIS Calcaneus is indicated for fractures of the calcaneus. |
| 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)
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| 510(k) Summary | |
|---|---|
| Proprietary Name: | VariAx 2 MIS Calcaneus |
| Common Name: | Single/multiple component metallic bone fixation appliances |
| and accessories (21 CFR 888.3030) | |
| Regulation Description: | Single/multiple component metallic bone fixation appliances |
| and accessories (21 CFR 888.3030) | |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | HRS |
| Device Class: | Class II |
| Sponsor: | Stryker GmbH |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Jonathan Schell, RAC |
| Sr. Staff Regulatory Affairs Specialist | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: 484-889-5804 | |
| Fax: 201-831-6500 | |
| Date Prepared: | May 6, 2022 |
| Predicate: | K063875: Stryker Foot Plating System |
| Additional Predicate: | K132898: Zimmer Biomet A.L.P.S. Calcaneal Plating System |
Description
This Traditional 510(k) submission is submitted to the U.S. FDA to provide authorization to market the VariAx 2 MIS Calcaneus plates. The goal of the Subject Device VariAx 2 MIS Calcaneus is to offer a comprehensive range of calcaneal implants and instruments in one system utilizing the VariAx 2 platform technology and SOMA database for the design of the plates.
The Subject Device VariAx 2 MIS Calcaneus has an equivalent Intended Use and Indications for Use as the Predicate Device and shares the same principle of operation.
Intended Use
Stryker VariAx 2 MIS Calcaneus is a non-active implant(s) intended to provide temporary stabilization for bones or bone fragments.
K221346 - Page 1 of 2
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Indications for Use
Stryker VariAx 2 MIS Calcaneus is indicated for fractures of the calcaneus.
Summary of Technologies
A comparison of the Subject Device VariAx 2 MIS Calcaneus shows that the Subject Device is substantially equivalent to the Predicate Device regarding Intended Use, material, design, and operational principle.
Non-Clinical Testing
- . The Subject Device(s) biocompatibility profile is equivalent to the previously cleared Reference Device(s) regarding material formulation, processing, sterilization, and geometry.
- The Subject Device sterilization methods and parameters remain the same as the Predicate Device.
- Verification testing (ASTM F382-17) was performed on the Subject Device and the acceptance criterion was fulfilled.
- MR compatibility testing was conducted on the Subject Device.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The Subject Device VariAx 2 MIS Calcaneus has an equivalent Intended Use and Indications for Use as the Predicate Device, and equivalent technological characteristics to the Predicate Device. Therefore, the information provided in this submission demonstrates substantial equivalence of the Subject Device to the Predicate Device.