(49 days)
No
The document describes a traditional surgical implant (bone plates and screws) and its mechanical testing, with no mention of software, algorithms, or AI/ML terms.
No.
The device is used for internal fixation of small bone fractures, which is a structural or mechanical support function, not a therapeutic one. It does not actively treat or heal the condition but provides stability.
No
The device is an internal fixation system (plates and screws) used to treat small bone fractures, primarily distal radius fractures. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "line extension to the VariAx Distal Radius Plating" and consists of "multiple internal fixation plates" and "locking screws, non-locking screws, locking pegs, and partially threaded screws," which are all physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "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 description details "internal fixation plates," "locking screws," "non-locking screws," "locking pegs," and "partially threaded screws." These are all components of a surgical implant system.
- 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 screening.
IVD devices are used outside the body to analyze samples, while this device is implanted inside the body to treat a physical condition.
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. Food and Drug Administration to provide authorization to market a line extension to the VariAx Distal Radius Plating, which was cleared in K04022, as the Universal Distal Radius System. The subject plate consists of distal radius fragment specific plates (lateral and dorsal medial). The subject components will be available sterile and non-sterile. The VariAx Distal Radius Plating System consists of multiple internal fixation plates in varying lengths and widths. The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, K132502 and K140769.
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. The testing demonstrated that the subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the TriMed Bone Plates (K060041), 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)
K040022, K080667, K132502, K140769
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
510(k) Summary
JUL 1 8 2014
Proprietary Name:
VariAx Distal Radius Plating System
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:
Product Codes:
Sponsor:
Contact Person:
Class II
HRS: Plate, Fixation, Bone HWC: Screw, Fixation, Bon
Stryker Leibinger GmbH & Co.KG
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:
May 29, 2014
Description
This Traditional 510(k) submission is being supplied to the U.S. Food and Drug Administration to provide authorization to market a line extension to the VariAx Distal Radius Plating, which was cleared in K04022, as the Universal Distal Radius System. The subject plate consists of distal radius fragment specific plates (lateral and dorsal medial). The subject components will be available sterile and non-sterile. The VariAx Distal Radius Plating System consists of multiple internal fixation plates in varying lengths and widths. The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, K132502 and K140769.
1
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.
Summary of Technologies
Device comparison showed that subject device is substantially equivalent to the TriMed Wrist Plates (K060041) in regards to intended use, and operational principles for use for internal fixation for fractures of the bones in the distal radius.
Non-Clinical Test
Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence. The testing demonstrated that the subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the TriMed Bone Plates (K060041), The following testing was performed "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008."
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 device identified throughout this submission.
2
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
July 18, 2014
Stryker Leibinger GmbH & Co.KG Mr. Elijah N. Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430
Re: K141430 Trade/Device Name: VariAx Distal Radius Plating 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: May 29, 2014 Received: May 30, 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 Acts 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
3
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 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" (21CFR 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,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K141430 page 1 of 1
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) K141430
Device Name
VariAx Distal Radius Plating System
Indications for Use (Describe)
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, and malunions.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Heath (CDRH) (Signature)
Elizabet标办公Frank -S
Division of Orthopedic Devices
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