(51 days)
No
The device description and performance studies focus on the mechanical properties and equivalence of the plates and screws, with no mention of AI or ML technology.
No.
This device is a fixation device (plates and screws) used for wrist arthrodesis and fracture fixation, which supports healing but does not actively provide therapy in the medical sense.
No
The device is a fixation device that consists of plates and screws intended for wrist arthrodesis and fracture fixation; it is used for treatment, not diagnosis.
No
The device description explicitly states it consists of plates and screws made of titanium, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
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 for diagnosis, monitoring, or screening.
- Device Description: The Stryker VariAx 2 Wrist Fusion System is a fixation device consisting of plates and screws made of titanium. It is designed to be surgically implanted to stabilize bones in the wrist.
- Intended Use: The intended use is for wrist arthrodesis and fixation of fractures. This is a surgical procedure performed directly on the patient's body, not on a specimen taken from the body.
The description clearly indicates a surgically implanted device used for structural support and stabilization within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker VariAx 2 Wrist Fusion is indicated for wrist arthrodess and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications include:
- Post-traumatic arthritis of the joints of the wrist
- Rheumatoid wrist deformities requiring restoration
- Complex carpal instability
- Post-septic arthritis of the wrist
- Severe unremitting wrist pain related to motion
- Brachial plexus nerve palsies
- Tumor resection
- Spastic deformities
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
VariAx 2 Wrist Fusion System is a fixation device that consists of plates with different design (standard bend, short bend, and straight) manufactured from Commercially Pure Titanium Grade 2 (ASTM F67). The plates will be available sterile and non-sterile. VariAx 2 Wrist Fusion System will be used with locking and non-locking screws (2.3mm, 2.7 and 3.5mm) previously cleared in K040022 (Stryker® Leibinger Universal Distal Radius System), K073527 (VariAx™ Elbow System), K080667 (VariAx™ Distal Radius Torx Screws), and K140769 (VariAx 2 System). VariAx 2 Wrist Fusion System will be used with new and existing instruments previously cleared in K101056 (VariAx Elbow System), K130009 (VariAx 2 Compression Plating System), and K140769 (VariAx 2 System).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, carpus
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 laboratory testing was performed on the worst case subject plates to determine substantial equivalence. Mechanical testing was performed with compliance to ASTM F382-14 'Standard specification and test method for metallic bone plates'. Testing demonstrated that VariAx 2 Wrist Fusion System is equivalent in mechanical performance to the predicate device, the Synthes Wrist Fusion Plates (K000558).
The following testing was performed:
- Dynamic Cantilever Bending Testing (fatigue strength)
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.
K040022, K073527, K080667, K140769, K101056, K130009
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three profiles facing right, representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2015
Stryker Trauma Ag Dr. Heike Gustke Regulatory Affairs Specialist, Trauma & Extremities Prof.- Kuntscher- Str. 1-5 Schoenkirchen, 2432 DE Germany
Re: K151178
Trade/Device Name: Variax 2 Wrist Fusion 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 Dated: April 29, 2015 Received: May 4, 2015
Dear Dr. Heike Gustke:
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, 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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/ResourcesforYou/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-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.
Mark N. Melkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151178
Device Name
V ariAx 2 Wrist Fusion System
Indications for Use (Describe)
The Stryker VariAx 2 Wrist Fusion is indicated for wrist arthrodess and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications include:
specific indications include:
-
Post-traumatic arthritis of the joints of the
-
· Post-traumatic arthritis of the joints of the wrist · Rheumatoid wrist deformities requiring restoration
-
· Complex carpal instability
-
· Post-septic arthritis of the wrist
-
· Severe unremitting wrist pain related to motion
-
· Brachial plexus nerve palsies
-
· Tumor resection
-
· Spastic deformities
Type of Use (Select one or both, as applicable)
X 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 F ood 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."
3
6 510(k) Summary
| Proprietary Name: | VariAx 2 Wrist Fusion System |
|---|---|
| Common Name: | Bone Plates |
| Regulation Description: | Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | HRS (Plate, Fixation, Bone) |
| Device Class: | Class II |
| Sponsor: | Stryker Trauma AG |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Dr. Heike Gustke |
| Regulatory Affairs Specialist | |
| Prof.-Kuentscher-Str. 1-5 | |
| 24232 Schoenkirchen / Germany | |
| heike.gustke@stryker.com | |
| Phone: +49 4348 702 637 | |
| Fax: +49 4348 702 8637 | |
| Date Prepared: | April 29, 2015 |
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new VariAx 2 Wrist Fusion System.
VariAx 2 Wrist Fusion System is a fixation device that consists of plates with different design (standard bend, short bend, and straight) manufactured from Commercially Pure Titanium Grade 2 (ASTM F67). The plates will be available sterile and non-sterile. VariAx 2 Wrist Fusion System will be used with locking and non-locking screws (2.3mm, 2.7 and 3.5mm) previously cleared in K040022 (Stryker® Leibinger Universal Distal Radius System), K073527
4
(VariAx™ Elbow System), K080667 (VariAx™ Distal Radius Torx Screws), and K140769 (VariAx 2 System). VariAx 2 Wrist Fusion System will be used with new and existing instruments previously cleared in K101056 (VariAx Elbow System), K130009 (VariAx 2 Compression Plating System), and K140769 (VariAx 2 System).
Intended Use
The Stryker VariAx 2 Wrist Fusion System is indicated for wrist arthrodesis and fixation of fractures in patients with wrist arthritis of fractures of other small bones of the carpus.
Indications for Use
The Stryker VariAx 2 Wrist Fusion System is indicated for wrist arthrodesis and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications include:
- Post-traumatic arthritis of the joints of the wrist .
- Rheumatoid wrist deformities requiring restoration ●
- Complex carpal instability ●
- Post-septic arthritis of the wrist ●
- Severe unremitting wrist pain related to motion
- Brachial plexus nerve palsies
- o Tumor resection
- Spastic deformities
Summary of Technologies
Device comparison demonstrated that VariAx 2 Wrist Fusion System is substantially equivalent to the Synthes Wrist Fusion Plates (K000558) in regards to intended use, material, design, and operational principles.
Non-Clinical Test
Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence. Mechanical testing was performed with compliance to ASTM F382-14 'Standard specification and test method for metallic bone plates'. Testing demonstrated that
5
VariAx 2 Wrist Fusion System is equivalent in mechanical performance to the predicate device,
the Synthes Wrist Fusion Plates (K000558).
The following testing was performed:
- Dynamic Cantilever Bending Testing (fatigue strength)
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The VariAx 2 Wrist Fusion System is substantially equivalent to the predicate device identified in this premarket notification.