(45 days)
Numelock™ II System, Stryker® Locked Plating System, Stryker® Plating System
Not Found
No
The description focuses on the mechanical design and function of bone plates and screws, with no mention of AI or ML.
Yes
Explanation: The device is intended for the temporary stabilization of long bone fractures, which is a therapeutic intervention aimed at treating injuries.
No
The device is a plating system (VariAx™ Locking Plate System) used for the temporary stabilization of long bone fractures, non-unions, malunions, osteotomies, and bone reconstruction, which are therapeutic interventions rather than diagnostic processes.
No
The device description clearly describes physical components (plates, screws, Kirschner wires) used for bone fixation, indicating it is a hardware medical device.
Based on the provided information, the VariAx™ Locking Plate System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "temporary stabilization of long bone fractures." This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of plates and screws designed for surgical implantation to fix bones. This is consistent with a surgical implant, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. The VariAx™ Locking Plate System is used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
The VariAx™ Locking Plate System is intended for use in the temporary stabilization of long bone fractures, including but not limited to:
- Proximal and distal fractures including joint fractures of the humerus, tibia and other long bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, intra-articular condylar fractures
- Diaphyseal fractures
- Ankle fractures
- Simple, comminuted and depression fractures
- Non-unions and malunions
- Osteotomies and bone reconstruction
- Fractures in normal or osteoporotic bone
Product codes
KTT
Device Description
This submission is a line extension to the Numelock™ II System and the Stryker® Locked Plating System for various types of locking plates, locking screws and non-locking screws. Plates will be based on the design of the monoaxial plates in the Stryker® Locked Plating System and the polyaxial locking mechanism of the Numelock 10 II plates. The subject plates have locking and non-locking holes and are used with the Ø4.0mm VariAx™ Universal Screws. There is a fully threaded, self-tapping screw and a partially threaded style of screw. All screws will be available sterile and non-sterile. The plates also have holes for standard Kirschner wires to enhance primary plate and fracture fixation or they can be used as suture anchors. Also, compression of the can be applied to the plate using the Universal Screw and act as a lag screw by pulling the bone toward the plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone, humerus, tibia, ankle
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)
FEA and mechanical testing was conducted to compare the strength of the new plates and screws to other plates and screws on the market. The results demonstrate that the subject components are substantially equivalent in strength to the predicate components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Numelock™ II System, Stryker® Locked Plating System, Stryker® Plating System
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.
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510(k) Summary of Safety and Effectiveness VariAx™ Locking Plate System
APR 2 1 2006
| Proprietary Name: | VariAx™ Locking Plate System |
|---|---|
| Common Name: | Bone plates and screws |
| Classification Name/Reference: | Single/multiple component metallic bone fixation |
| appliances and accessories, 21 CFR §888.3030 | |
| Device Product Code: | 87 KTT |
| Proposed Regulatory Class: | |
| For Information contact: | Class II |
| Vivian Kelly, Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5581 Fax: (201) 831-6038 | |
| Date Summary Prepared: | March 6, 2006 |
Description
This submission is a line extension to the Numelock™ II System and the Stryker® Locked Plating System for various types of locking plates, locking screws and non-locking screws. Plates will be based on the design of the monoaxial plates in the Stryker® Locked Plating System and the polyaxial locking mechanism of the Numelock 10 II plates. The subject plates have locking and non-locking holes and are used with the Ø4.0mm VariAx™ Universal Screws. There is a fully threaded, self-tapping screw and a partially threaded style of screw. All screws will be available sterile and non-sterile. The plates also have holes for standard Kirschner wires to enhance primary plate and fracture fixation or they can be used as suture anchors. Also, compression of the can be applied to the plate using the Universal Screw and act as a lag screw by pulling the bone toward the plate.
Indications:
The VariAx™ Locking Plate System is intended for use in the temporary stabilization of long bone fractures, including but not limited to:
- Proximal and distal fractures including joint fractures of the humerus, tibia and other long . bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, intra-articular condylar fractures �
- Diaphyseal fractures .
- . Ankle fractures
- Simple, comminuted and depression fractures .
- � Non-unions and malunions
- Osteotomies and bone reconstruction .
- Fractures in normal or osteoporotic bone .
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Substantial Equivalence:
The VariAx™ Locking Plate System is substantially equivalent to other plating systems in regards to intended use, design, materials, and operational principles as internal fixation components such as the Numelock™ II System, Stryker® Locked Plating System and the Stryker® Plating System. FEA and mechanical testing was conducted to compare the strength of the new plates and screws to other plates and screws on the market. The results demonstrate that the subject components are substantially equivalent in strength to the predicate components.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human figures in profile, arranged in a row and facing to the right. These figures are rendered in a simple, abstract style with flowing lines. The figures are encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2005
Howmedica Osteonics Corporation c/o Ms. Vivian Kelly Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K060613
Trade/Device Name: VariAx™ Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 6. 2006 Received: March 7, 2006
Dear Ms. Kelly:
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. Ilsting of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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 vour 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): good manufacturing practice requirements as set
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Page 2 - Ms. Vivian Kelly
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.ida.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Haki Limes V.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VariAxTM Locking Plate System
Indications for Use:
The VariAx™ Locking Plate System is intended for use in the temporary stabilization of long bone fractures, including but not limited to:
- Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, intra-articular condylar . fractures
- Diaphyseal fractures .
- . Ankle fractures
- . Simple, comminuted and depression fractures
- . Non-unions and malunions
- . Osteotomies and bone reconstruction
- Fractures in normal or osteoporotic bone ●
Prescription Use X Over-The-Counter Use AND/OR (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
Michel (emer)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K060013
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