(59 days)
No
The document describes a system of screws, washers, and instruments for internal fixation, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is used for fracture fixation, reconstruction, and arthrodesis, which are therapeutic medical interventions.
No
The VariAx 2 System is described as a system for internal fixation applications (e.g., fracture fixation, reconstruction) and does not mention any function related to identifying, measuring, or monitoring a medical condition.
No
The device description explicitly states it is composed of sterile and nonsterile screws, washers, and instruments, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The VariAx 2 System is described as a system for internal fixation applications composed of screws, washers, and instruments. These are implanted within the body to stabilize bones.
- Intended Use: The intended use is for the treatment of bone conditions and procedures like fracture fixation, revision, reconstruction, etc. This involves surgical intervention and the placement of implants within the body.
The description clearly indicates that this device is a surgical implant used for musculoskeletal repair, not a device used to analyze samples outside of the body.
N/A
Intended Use / Indications for Use
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
HWC, HRS, HTN
Device Description
VariAx 2 is a system 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 plating systems. These devices are made of 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
Not Found
Indicated Patient Age Range
adult and pediatric patients, where the implant would not cross open growth plates
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 Testing: No new devices were introduced with this submission. No mechanical testing was presented.
Clinical Testing: Clinical testing was not a requirement of this submission.
Key Metrics
Not Found
Predicate Device(s)
VariAx 2 System, K140769, ALPS Small Bone Locked Plating System, K101240
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2017
Stryker GmbH Paul Nelson Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430
Re: K173135
Trade/Device Name: VariAx 2 System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC. HRS. HTN Dated: September 28, 2017 Received: September 29, 2017
Dear Paul 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, 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173135
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)
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510(k) Summary
| Submitter: | Stryker GmbH
Bohnackerweg 1
CH-2545 Selzach
Switzerland |
|-----------------------|-----------------------------------------------------------------------------------------------------|
| Contact Person: | Paul Nelson
Senior Regulatory Affairs Specialist
Phone: (201) 831-5691
Fax: (201) 831-6500 |
| Date Prepared: | September 28, 2017 |
| Name of Device: | VariAx 2 System |
| Common or Usual Name: | Screw, Fixation, Bone
Plate, fixation, Bone
Washer, Bolt, Nut |
| | |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| | (21 CFR § 888.3040) |
| | Single/multiple component metallic bone fixation |
| | appliances and accessories (21 CFR § 888.3030) |
| Regulatory Class: | Class II |
| Product Codes: | HWC, HRS, HTN |
| Primary Predicate: | VariAx 2 System, K140769 |
| Additional Predicate: | ALPS Small Bone Locked Plating System, K101240 |
Description:
VariAx 2 is a system 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 plating systems. These devices are made of titanium alloy, with Type III anodization, and are available in a variety of sizes and diameters, as well as locking and non-locking types.
This submission builds on K140769 by simplifying and clarifying the indications statement, and by expanding the treatment population to include pediatric patients.
4
Indications for Use:
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 subject VariAx 2 System is substantially equivalent to the previously cleared VariAx 2 system, K140769, and to the ALPS Small Bone Locked Plating system, K101240, in regards to intended use, material, design, and operating principles.
Performance Data:
Non-Clinical Testing
No new devices were introduced with this submission. No mechanical testing was presented.
Clinical Testing
Clinical testing was not a requirement of this submission.
Conclusion:
The VariAx 2 System described in this submission is identical to the previously cleared, and primary predicate, K140769. Compared to the ALPS Small Bone Locked Plating System, the subject system shares similar intended use, patient population, and principles of operation, as well as similar technological characteristics and materials. Based on these attributes, the subject system is deemed substantially equivalent.