(133 days)
No
The device description and intended use focus on the physical components (plates and screws) for fracture fixation. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The submission is for a new packaging configuration of existing, cleared devices.
Yes
The device is intended for internal fixation of small bone fractures, osteotomies, and revision procedures, which are all therapeutic interventions designed to treat medical conditions.
No
The device is a plating system with screws intended for internal fixation of bone fractures and other orthopedic procedures, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components (plates and screws made of titanium) and instrumentation, which are hardware. The submission is for a new packaging configuration of these 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 the device is for "internal fixation of small bone fractures," "Osteotomies," "non-unions," and "malunions." These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as "plates and screws" and "instrumentation," which are physical implants and tools used in surgery.
- 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 biological samples. This device is an implantable surgical device used inside the body.
N/A
Intended Use / Indications for Use
The VariAx Distal Radius Plate System is intended for internal fixation of small bone fractures, primarily including distal radius fractures. The VariAx 2 System is intended for internal fixation.
Indications for Use
VariAx Distal Radius Plating System
The VariAx Distal Radius Plating 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 mal-unions.
VariAx 2 System
The Stryker VariAx 2 System screws, when used in coniunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:
- . Internal fracture fixation;
- Osteotomies;
- Revision procedures such as non-unions or mal-unions;
In addition, the following indications are specific to the devices listed below:
- T8 2.4mm Screws & T8 2.0mmn Locking Peg: For use in small bones, primarily ● including the Distal Radius, in the treatment of:
- Compression fractures; o
- Intra-articular and extra-articular fractures; O
- Displaced fractures; o
- Reconstruction procedures; o
- . T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, mid- and hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, o
- Displaced and compression fractures of the Distal Radius; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the O Foot & Ankle;
- Reconstruction procedures in the Foot & Ankle and Distal Radius; o
- TI0 3.5mmn and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and O Proximal Ulna;
- Single, segmental and comminuted fractures; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the O Foot & Ankle;
- Normal bone density or osteopenic bone. o
Product codes
HRS, HWC
Device Description
This Traditional 510(k) submission is intended to provide information on a new packaging configuration of the VariAx Distal Radius Plates. The components of the VariAx Distal Radius System remain identical to those in the most recently cleared in K141430. No new components have been added to the system.
Briefly, the VariAx Distal Radius Plating System consists of several different plates and screws manufactured from Commercially Pure Titanium Grade 2 (ASTM F67) and Titanium Alloy (ASTM F136), respectively. The VariAx 2 System (screws) (cleared under K140769) include a series of Titanium Alloy (ASTM F136) screws intended to be used across the entire VariAx line. The VariAx 2 T8 2.0 mm peg, T8 2.4 mm and T8 2.7 mm screws, and washer are specifically indicated for use with VariAx Distal Radius Plating System. All implants are provided sterile and non-sterile.
The new packaging configuration, called the VariAx 2 Xpress Distal Radius Kit, includes already cleared sterile packed VariAx Distal Radius Plates and VariAx 2 T8 2.7 mm screws along with single use class I exempt instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones, primarily including distal radius, fore, mid- and hind Foot and Ankle, Radius, Ulna, Clavicle, Humerus, Distal Tibia and Fibula, Distal Humerus and Proximal Ulna.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 Test:
LAL testing has been performed to establish that the subject device meets the specified 20EU/device limit.
No additional non-clinical laboratory testing was required for this submission as there are no new components being added to the system.
Clinical Testing:
Clinical testing was not required for this submission because there are no new components being added to the system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VariAx Distal Radius Plating System, K141430
Reference Device(s)
VariAx 2 System (screws), 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2017
Stryker GmbH Irene Bacalocostantis, PhD Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K162841 Trade/Device Name: VariAx Distal Radius Plate System, VariAx 2 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: January 17, 2017 Received: January 18, 2017
Dear Dr. Bacalocostantis:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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) K162481
Device Name
VariAx Distal Radius Plating System
Indications for Use (Describe)
The VariAx Distal Radius Plating 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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K162841
Device Name VariAx 2 System
Indications for Use (Describe)
The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:
· Internal fracture fixation;
· Osteotomies;
· Revision procedures such as non-unions or mal-unions;
In addition, the following indications are specific to the devices listed below:
· T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of:
o Compression fractures:
o Intra-articular and extra-articular fractures;
o Displaced fractures:
o Reconstruction procedures:
· T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, mid- and hind Foot and Ankle, in the treatment of:
o Intra-articular and extra-articular fractures of the Distal Radius.
o Displaced and compression fractures of the Distal Radius:
o Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle;
o Reconstruction procedures in the Foot & Ankle and Distal Radius:
· T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:
o Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna;
- o Single, segmental and comminuted fractures;
o Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle;
o Normal bone density or osteopenic bone.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
| Proprietary Name: | VariAx Distal Radius Plating System
VariAx 2 System |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Plates
Bone Screws |
| Regulation Number &
Description: | 21 CFR 888.3030; Single/multiple component
metallic bone fixation appliances and accessories |
| | 21 CFR 888.3040; Smooth or threaded metallic bone
fixation fastener |
| Product Code: | HRS (Plate, Fixation, Bone)
HWC (Screw, Fixation, Bone) |
| Device Class: | Class II |
| Sponsor: | Stryker Trauma GmbH
Bohnackerweg 1
2545 Selzach / Switzerland |
| Contact Person: | Irene Bacalocostantis
Sr. Regulatory Affairs Specialist
325 Corporate Drive
07430 Mahwah / New Jersey
irene.bacalocostantis@stryker.com
Phone: +1 201 831 6797 |
| Additional Contact Person: Tina Mornak | Sr. Regulatory Affairs Specialist
tina.mornak@stryker.com
Phone: +1 201 831 6365 |
| Date Prepared: | December 13, 2016 |
| Primary Predicate:
Reference Predicate: | VariAx Distal Radius Plating System, K141430
VariAx 2 System (screws), K140769 |
| Description | |
This Traditional 510(k) submission is intended to provide information on a new packaging configuration of the VariAx Distal Radius Plates. The components of the VariAx Distal
6
Radius System remain identical to those in the most recently cleared in K141430. No new components have been added to the system.
Briefly, the VariAx Distal Radius Plating System consists of several different plates and screws manufactured from Commercially Pure Titanium Grade 2 (ASTM F67) and Titanium Alloy (ASTM F136), respectively. The VariAx 2 System (screws) (cleared under K140769) include a series of Titanium Alloy (ASTM F136) screws intended to be used across the entire VariAx line. The VariAx 2 T8 2.0 mm peg, T8 2.4 mm and T8 2.7 mm screws, and washer are specifically indicated for use with VariAx Distal Radius Plating System. All implants are provided sterile and non-sterile.
The new packaging configuration, called the VariAx 2 Xpress Distal Radius Kit, includes already cleared sterile packed VariAx Distal Radius Plates and VariAx 2 T8 2.7 mm screws along with single use class I exempt instrumentation.
Intended Use
The VariAx Distal Radius Plate System is intended for internal fixation of small bone fractures, primarily including distal radius fractures. The VariAx 2 System is intended for internal fixation.
Indications for Use
VariAx Distal Radius Plating System
The VariAx Distal Radius Plating 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 mal-unions.
VariAx 2 System
The Stryker VariAx 2 System screws, when used in coniunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:
- . Internal fracture fixation;
- Osteotomies;
- Revision procedures such as non-unions or mal-unions;
7
In addition, the following indications are specific to the devices listed below:
- T8 2.4mm Screws & T8 2.0mmn Locking Peg: For use in small bones, primarily ● including the Distal Radius, in the treatment of:
- Compression fractures; o
- Intra-articular and extra-articular fractures; O
- Displaced fractures; o
- Reconstruction procedures; o
- . T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, mid- and hind Foot and Ankle, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Radius, o
- Displaced and compression fractures of the Distal Radius; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the O Foot & Ankle;
- Reconstruction procedures in the Foot & Ankle and Distal Radius; o
- TI0 3.5mmn and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:
- Intra-articular and extra-articular fractures of the Distal Humerus and O Proximal Ulna;
- Single, segmental and comminuted fractures; o
- Replantation, joint fusions or arthrodesis and corrective osteotomies in the O Foot & Ankle;
- Normal bone density or osteopenic bone. o
Summary of Technologies
There have not been any modifications made to the VariAx Distal Radius Plating System or the VariAx 2 System since of the VariAx Distal Radius Plating System (K141430) and of the VariAx 2 System (K140769).
Non-Clinical Test
LAL testing has been performed to establish that the subject device meets the specified 20EU/device limit.
No additional non-clinical laboratory testing was required for this submission as there are no new components being added to the system.
Clinical Testing
Clinical testing was not required for this submission because there are no new components being added to the system.
8
Conclusion
This submission is only intended to introduce a new packaging configuration where the VariAx Distal Radius Plating System and VariAx 2 T8 2.7mm screws are packaged together. The VariAx Distal Radius System and the VariAx 2 System remain identical to the predicate system cleared under K141430 and K140769, respectively.