(88 days)
No
The summary describes a traditional surgical plating system for bone fractures and does not mention any AI or ML components or functionalities.
Yes
The device is described as an internal fixation system for small bone fractures, particularly distal radius fractures, which is a therapeutic intervention.
No
The device is an internal fixation system (plates and screws) used for treating bone fractures, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a "line extension to the VariAx Distal Radius Plating System" consisting of "multiple internal fixation plates" and "screws, non-locking screws, locking pegs, and partially threaded screws." These are physical hardware components used for internal fixation of bone fractures.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "internal fixation of small bone fractures, primarily including distal radius fractures." This describes a surgical implant used to stabilize bone fractures within the body.
- Device Description: The device is described as "multiple internal fixation plates in varying lengths and widths" and used with "locking screws, non-locking screws, locking pegs, and partially threaded screws." These are all components of a surgical implant system.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or diagnostic purposes.
The device described is a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.
Indications include:
- . compression fractures
- intra-articular and extra-articular fractures .
- . displaced fractures
Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.
Product codes
HRS, HWC
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market a line extension to the VariAx Distal Radius Plating System, which was cleared in K040022, as the Universal Distal Radius System. The VariAx Distal Radius Plating System Line Extension consists of multiple internal fixation plates in varying lengths and widths. The portfolio of plates is being extended to include new plate width (intermediate) and new plate length (extrashort).
The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, and K132502. The subject components will be available sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (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. Testing demonstrated that the subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the currently marketed predicate devices. The following testing was performed "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008."
Clinical testing was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K133974
510(k) Summary
| Proprietary Name: | VariAx Distal Radius Plating System Line Extension |
|---|---|
| Common Name: | Bone Plates |
| Bone Screws | |
| Classification Name and Reference: | Single/multiple component metallic bone fixation appliance |
| and accessories 21 CFR §888.3030 | |
| Smooth or threaded metallic bone fixation fastener | |
| 21 CFR §888.3040 | |
| Regulatory Class: | Class II |
| Product Codes: | HRS: Plate, Fixation, Bone |
| HWC: Screw, Fixation, Bone | |
| Sponsor: | Stryker Leibinger GmbH & Co.KG |
| Contact Person: | Elijah N. Wreh |
| Regulatory Affairs Specialist | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| elijah.wreh@stryker.com | |
| Phone: 201-831-5691 | |
| Fax: 201-831-4691 | |
| Date Prepared: | December 23, 2013 |
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market a line extension to the VariAx Distal Radius Plating System, which was cleared in K040022, as the Universal Distal Radius System. The VariAx Distal Radius Plating System Line Extension consists of multiple internal fixation plates in varying lengths and widths. The portfolio of plates is being extended to include new plate width (intermediate) and new plate length (extrashort).
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K133974
The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, and K132502. The subject components will be available sterile and non-sterile.
Intended Use
The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.
Indications for Use
Indications include:
- . compression fractures
- intra-articular and extra-articular fractures .
- . displaced fractures
Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.
Substantial Equivalence
The subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the VariAx Distal Radius Plating System (K040022) and the VariAx Distal Radius Line Extension of XXL Plates (K100271) in regards to intended use, design, materials, and operational principles for use for internal fixation for fractures and reconstruction of the small bones in the distal radius.
Non-Clinical Test
Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence. Testing demonstrated that the subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the currently marketed predicate devices. The following testing was performed "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008."
2
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject devices which are being added to the VariAx Distal Radius Plating System are substantially equivalent to the predicate devices identified throughout this submission.
3
Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2014 ·
Stryker Leibinger GmbH & Co. KG Mr. Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K133974
Trade/Device Name: VariAx Distal Radius Plating System Line Extension 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: February 27, 2014 Received: February 28, 2014
Dear Mr. Wreh:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 – Mr. Elijah N. Wreh
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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Ronald P. Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if Known): __K133974 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
VariAx Distal Radius Plating System Line Extension Device Name:
The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.
Indications for Use:
- compression fractures .
- intra-articular and extra-articular fractures .
- displaced fractures .
Following additional indications apply only for the XXL Volar Distal Radius Plates:
Osteotomies, non-unions, and malunions.
Over-The-Counter Use AND/OR Prescription Use _ x (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices