(103 days)
No
The summary describes a system of plates and screws for bone fixation, with no mention of AI or ML technology. The performance studies are focused on mechanical and material properties.
No.
The device is indicated for the fixation of fractures, osteotomies, nonunions, and malunions, which are structural repairs rather than treatments that restore health or normal function.
No
The device is indicated for the fixation of fractures, osteotomies, nonunions, and malunions, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it consists of "anatomically pre-contoured plates" and "specialized instrumentation," which are physical hardware components. The performance studies also focus on the mechanical properties and biocompatibility of these physical implants and instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of fractures, osteotomies, nonunions and malunions of the bones of the hand and wrist". This describes a surgical implant used to physically stabilize bone structures.
- Device Description: The device is described as "anatomically pre-contoured plates" and "specialized instrumentation". These are physical devices used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an in vivo (within the body) surgical implant.
N/A
Intended Use / Indications for Use
The VariAx 2 Distal Radius System is indicated for the fixation of fractures, osteotomies, nonunions and malunions of the bones of the hand and wrist, including osteopenic bone.
Product codes
HRS, HWC
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the VariAx 2 Distal Radius System. This line extension consists of anatomically pre-contoured plates for the treatment of simple and complex fractures of the distal radius, together with specialized instrumentation.
All new plates are manufactured from CP Ti Grade 2 (Type II anodization) and are available in different sizes and left/right versions. The plates will be provided both non-sterile and sterile-packaged. They will use the well-established SmartLock technology to allow variable angle screw locking. The plates can be used with non-locking and locking VariAx 2 T8 screws. The VariAx 2 T8 screws have been previously cleared under K191412.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the hand and wrist, distal radius
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
Non-Clinical Performance: The new VariAx 2 Distal Radius plates are single use devices, available in sterile and non-sterile presentations. Sterile plates are sterilized by means of radiation. Comparative assessment to the predicate and reference systems demonstrated substantial equivalence. The following factors were considered:
- Engineering assessment of cross-section analysis in the fatigue area
- Plate/Screw interface: Static cantilever bending
- Plate/Screw interface: Dynamic cantilever bending
- Plate/Screw interface: Torque to failure
- MR assessment of magnetically induced displacement force per ASTM F2052, magnetically induced torque per ASTM F2213. RF-induced heating per ASTM F2182. and image artifacts per ASTM F2119.
- Packaging tests were performed according to ISO 11607-1 and ISO 11607-2.
- Biocompatibility evaluation according to ISO 10993-1
Clinical Performance: Clinical data was not needed for the subject devices to demonstrate substantial equivalence to the predicate devices.
Key results: Any differences do not raise new questions of safety and effectiveness; and The subject devices are at least as safe and effective as the legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
VariAx 2 Distal Radius System (K212581)
Reference Device(s)
VariAx Distal Radius Plating System (K133974)
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
March 25, 2024
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Stryker GmbH Ileana Freige Staff Specialist Regulatory Affairs Bohnackerweg 1 Selzach, 2545 Switzerland
Re: K233919
Trade/Device Name: VariAx 2 Distal Radius 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: December 13, 2023 Received: December 13, 2023
Dear Ileana Freige:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Tejen D. Soni -S
For
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
2
Indications for Use
Submission Number (if known)
Device Name
VariAx 2 Distal Radius System
Indications for Use (Describe)
The VariAx 2 Distal Radius System is indicated for the fixation of fractures, osteotomies, nonunions and malunions of the bones of the hand and wrist, including osteopenic bone.
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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3
510(k) Summary
| Proprietary name: | VariAx 2 Distal Radius System |
|---|---|
| Common name: | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Primary Product Code: | HRS |
| Regulation Number: | 21 CFR 888.3030: Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Associated Product Code: | HWC |
| Regulation Number: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Sponsor: | Stryker GmbH |
| Bohnackerweg 1 | |
| 2545 Selzach, Switzerland | |
| Contact Person: | Ileana Freige |
| Staff Specialist, Regulatory Affairs | |
| Dr. Homer Stryker Strasse 1 | |
| 2545 Selzach, Switzerland | |
| Phone: +41 79 757 61 27 | |
| ileana.freige@stryker.com | |
| Date Prepared: | December 13, 2023 |
| Predicate Device: | VariAx 2 Distal Radius System (K212581) |
| Reference Device: | VariAx Distal Radius Plating System (K133974) |
| Device Description: | This Traditional 510(k) submission is being supplied to the U.S. FDA |
| to gain clearance to market the new devices of the VariAx 2 Distal | |
| Radius System. This line extension consists of anatomically pre- | |
| contoured plates for the treatment of simple and complex fractures of | |
| the distal radius, together with specialized instrumentation. |
All new plates are manufactured from CP Ti Grade 2 (Type II
anodization) and are available in different sizes and left/right versions.
The plates will be provided both non-sterile and sterile-packaged. They
will use the well-established SmartLock technology to allow variable
angle screw locking. The plates can be used with non-locking and
locking VariAx 2 T8 screws. The VariAx 2 T8 screws have been
previously cleared under K191412. |
4
Indications for Use: The VariAx 2 Distal Radius System is indicated for the fixation of fractures, osteotomies, nonunions and malunions of the bones of the hand and wrist, including osteopenic bone. The intended use and indications of the subject devices are identical as Comparison to predicate device: those of the predicate devices. There is no change in the fundamental scientific technology shared by both the subject and predicate devices. Performance Data: Non-Clinical Performance: The new VariAx 2 Distal Radius plates are single use devices, available in sterile and non-sterile presentations. Sterile plates are sterilized by means of radiation. Comparative assessment to the predicate and reference systems demonstrated substantial equivalence. The following factors were considered: · Engineering assessment of cross-section analysis in the fatigue area · Plate/Screw interface: Static cantilever bending · Plate/Screw interface: Dynamic cantilever bending · Plate/Screw interface: Torque to failure · MR assessment of magnetically induced displacement force per ASTM F2052, magnetically induced torque per ASTM F2213. RF-induced heating per ASTM F2182. and image artifacts per ASTM F2119. · Packaging tests were performed according to ISO 11607-1 and ISO 11607-2. · Biocompatibility evaluation according to ISO 10993-1 Clinical Performance: Clinical data was not needed for the subject devices to demonstrate substantial equivalence to the predicate devices. The subject devices have identical intended use and indications for use Conclusion: as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using same materials and processes as the predicate devices. The performance analyses demonstrate that: · Any differences do not raise new questions of safety and effectiveness; and
- · The subject devices are at least as safe and effective as the legally marketed predicate devices.