(48 days)
No
The summary describes a line extension of a previously cleared bone plate system, focusing on material, size, and mechanical performance. There is no mention of AI or ML.
Yes
The device is intended for internal fixation in the clavicle for fractures, osteotomies, mal-unions, and non-unions, which are therapeutic interventions.
No
The device is an orthopedic fixation system (plates and screws) used for internal fixation of clavicle fractures, not for diagnosing conditions.
No
The device description clearly states it consists of physical plates and screws made of titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "internal fixation in the clavicle." This describes a surgical procedure to stabilize a bone fracture.
- Device Description: The device is a system of plates and screws made of titanium, designed to be implanted in the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The Variax Clavicle System is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Variax Clavicle System is intended for use in internal fixation in the clavicle.
The Variax Clavicle System Anterior/Superior Lateral and Anterior/Superior Midshaft Plates are indicated for fixation of single, segmental and comminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.
Product codes
HRS, HWC
Device Description
The Variax Clavicle System consists of anatomically contoured Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates which were previously cleared in K113760. The plates are manufactured from Titanium alloy per ASTM F136 and Commercially Pure Titanium per ASTM F 67. The plates are fixed to the clavicle using 3.5mm or 2.7mm locking or non-locking screws. This Special 510(k) submission is intended to introduce 145mm Superior Lateral Plates as a line extension to the currently marketed Superior Lateral Plates in the Variax Clavicle System. This will extend the range of plate sizes from 74mm-145mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle
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
Risk analysis was performed according to the requirements of ISO 14971:2007 Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. This evaluation demonstrated that the new plate length did not present a new worst case and that the same verification and validation methods were applied to the subject device in comparison to the previously cleared predicate (K113760) The analysis demonstrated that the subject Variax Clavicle System plates met performance requirements and are as safe and effective as their predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
MAR 0 5 2013
Page 1 of 2
. K130116
510(k) Summary
Variax Clavicle System Proprietary Name: Plate, Fixation, Bone Common Name: Classification Name and Reference: Single/multiple component metallic bone fixation appliances and accessories, 21 CFR §
Proposed Regulatory Class:
Product Codes:
HRS: HWC
Variax Clavicle
Class II
Predicate Devices:
Sponsor:
Contact Person:
Stryker Trauma AG Bohnackerweg 1 CH-2545 Selzach Switzerland
888.3030
Estela Celi Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-3461 estela.celi@stryker.com
January 15,2013
Device Description
Date Prepared:
The Variax Clavicle System consists of anatomically contoured Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates which were previously cleared in K113760. The plates are manufactured from Titanium alloy per ASTM F136 and Commercially Pure Titanium per ASTM F 67. The plates are fixed to the clavicle using 3.5mm or 2.7mm locking or non-locking screws. This Special 510(k) submission is intended to introduce 145mm Superior Lateral Plates as a line extension to the currently marketed Superior Lateral Plates in the Variax Clavicle System. This will extend the range of plate sizes from 74mm-145mm in length.
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1
Intended Use
The Variax Clavicle System is intended for use in internal fixation in the clavicle.
Indications for Use -
The Variax Clavicle System Anterior/Superior Lateral and Anterior/Superior Midshaft Plates are indicated for fixation of single, segmental and comminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.
Substantial Equivalence
The subject Superior Lateral Plates are substantially equivalent to the Superior Lateral Plates in the Variax Clavicle System cleared under K113760 in regards to intended use, design, materials, and operational principles as a bone fixation device.
Non-Clinical Testing
Risk analysis was performed according to the requirements of ISO 14971:2007 *Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. This evaluation demonstrated that the new plate length did not present a new worst case and that the same verification and validation methods were applied to the subject device in comparison to the previously cleared predicate (K113760) The analysis demonstrated that the subject Variax Clavicle System plates met performance requirements and are as safe and effective as their predicate devices.
Conclusion
The subject components of the Variax Clavicle System are substantially equivalent to the predicate device identified in this premarket notification.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with healthcare. The symbol features a staff with a snake winding around it, representing healing and medicine.
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
Letter dated: March 5, 2013
Stryker Trauma AG % Ms. Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K130116
Trade/Device Name: Variax Clavicle 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: February 4, 2013 Received: February 5, 2013
Dear Ms. Celi:
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. Ilisting 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
3
Page 2 - Ms. Estela Celi
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosüre
4
Indications for Use
510(k) Number (if known): K130116
Device Name: Variax Clavicle System
The Variax Clavicle Anterior/Superior Lateral and Anterior/Superior Midshaft Plates are indicated for fixation of single, segmental and comminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ·
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices