(55 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fixation, with no mention of AI or ML.
No
The device is described as a system for internal fixation of bones, typically used in orthopedic surgery, which is a structural support rather than a therapeutic treatment.
No
Explanation: The device is indicated for internal fixation of bones, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it is composed of sterile and nonsterile plates and instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "internal fixation of bones in the foot, ankle, hand, and adolescent (12 - 21 years) patients". This describes a surgical procedure for fixing bones, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is described as a system of "sterile and nonsterile plates, and instruments" used for "internal fixation". This aligns with surgical implants and tools, not diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The VariAx 2 Foot System is a surgical implant and instrument system used for structural support and fixation within the body.
N/A
Intended Use / Indications for Use
VariAx 2 Foot System is indicated for internal fixation of bones in the foot, ankle, hand, and adolescent (12 - 21 years) patients, which includes replantation, joint fusions, corrective osteotomies, and osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
VariAx 2 Foot System is a system used for internal fixation and is composed of sterile and nonsterile plates, and instruments. This system also uses compatible instruments and compatible screws from other systems. These contoured plates are made of Grade II, commercially pure titanium, with Type II anodization. They are available in a variety of sizes and shapes, and are designed to accept locking and non-locking screws, as well as k-wires for temporary fixation during initial placement.
This submission extends K141992 by introducing additional plates, additional instruments, and expands the indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones in the foot, ankle, hand, and wrist
Indicated Patient Age Range
adult and adolescent (12 - 21 years) 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
Comparative mechanical testing to predicate systems demonstrated substantial equivalence.
The following tests were performed:
- . Dynamic Bending
- o Static Stiffness
Testing demonstrated that the VariAx 2 Foot System is equivalent in mechanical performance to the predicate devices of the ORTHOLOC 2.0/2.4 Plate & Ortholoc 2.0/2.4 Screw system.
LAL testing was performed to establish that the subject devices meet the specified 20 EU/device limit.
Clinical Testing
Clinical testing was not a requirement of 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.
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DEPARTMENT OF HEALTH
May 8, 2017
Stryker GmbH Mr. Paul Nelson Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K170771
Trade/Device Name: VariAx 2 Foot 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: March 10, 2017 Received: March 14, 2017
Dear Mr. Nelson:
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. Isting 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name VariAx 2 Foot System
Indications for Use (Describe)
VariAx 2 Foot System is indicated for internal fixation of bones in the foot, ankle, hand, and adolescent (12 - 21 years) patients, which includes replantation, joint fusions, corrective osteotomies, and 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
| Submitter: | Stryker GmbH
Bohnackerweg 1
CH-2545 Selzach
Switzerland |
|------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Paul Nelson
Regulatory Affairs Specialist
Phone: (201) 831-5691
Fax: (201) 831-6500 |
| Date Prepared: | February 24, 2017 |
| Name of Device: | VariAx 2 Foot System |
| Common or Usual Name: | Bone Plates |
| Classification Name: | Single/multiple component metallic bone fixation appliances and
accessories
(21 CFR § 888.3030) |
| Regulatory Class: | Class II |
| Product Codes: | HRS |
| Primary Predicate: | VariAx 2 System, K141992 |
| Additional Predicates: | Ortholoc 2.0/2.4 Plate & Ortholoc 2.0/2.4 Screw, K090692 |
| Additional Predicates: | Modular Mini Fragment LCP System, K063049 |
Description:
VariAx 2 Foot System is a system used for internal fixation and is composed of sterile and nonsterile plates, and instruments. This system also uses compatible instruments and compatible screws from other systems. These contoured plates are made of Grade II, commercially pure titanium, with Type II anodization. They are available in a variety of sizes and shapes, and are designed to accept locking and non-locking screws, as well as k-wires for temporary fixation during initial placement.
This submission extends K141992 by introducing additional plates, additional instruments, and expands the indications.
Indications for Use:
VariAx 2 Foot System is indicated for internal fixation of bones in the foot, ankle, hand, and wrist in adult and adolescent (12 - 21 years) patients, which includes replantation, joint fusions, corrective osteotomies, and osteopenic bone.
4
Summary of Technologies:
A comparison of the systems demonstrated that the subject VariAx 2 Foot System is substantially equivalent to the previously cleared VariAx 2 system, K141992, to the Ortholoc 2.0/2.4 Plate & Ortholoc 2.0/2.4 Screw system, K090692, and to the Modular Mini Fragment LCP System, K063049, in regards to intended use, material, design, and operating principles.
Performance Data:
Non-Clinical Testing
Comparative mechanical testing to predicate systems demonstrated substantial equivalence.
The following tests were performed:
- . Dynamic Bending
- o Static Stiffness
Testing demonstrated that the VariAx 2 Foot System is equivalent in mechanical performance to the predicate devices of the ORTHOLOC 2.0/2.4 Plate & Ortholoc 2.0/2.4 Screw system.
LAL testing was performed to establish that the subject devices meet the specified 20 EU/device limit.
Clinical Testing
Clinical testing was not a requirement of this submission.
Conclusion:
With the exception of the additional components being introduced, the VariAx 2 Foot System described in this submission is identical to the previously cleared, and primary predicate, K141992. Compared to the Ortholoc 2.0/2.4 Plate & Ortholoc 2.0/2.4 Screw system, and to the Modular Mini Fragment LCP system reference predicates, the subject system shares similar intended use, patient population, and principles of operation, as well as similar technological characteristics and materials. Mechanical testing demonstrated that subject system performs as intended and at least as well as the predicates. Based on these attributes, the subject system is deemed substantially equivalent.