(105 days)
No
The document describes a mechanical implant (bone plates and screws) and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is an orthopedic implant for internal fixation of fractures and reconstruction of bones, not a therapeutic device in the sense of delivering treatment or therapy (e.g., medication, radiation, or physical therapy).
No
The device, Stryker XXL Volar Distal Radius Plates, is described as an internal fixation system for fractures and reconstruction of small bones, primarily the distal radius. This is a therapeutic device used for treatment, not for diagnosing conditions.
No
The device description clearly describes physical plates and screws used for internal fixation of bone fractures, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius." This describes a surgical implant used to stabilize bone fractures and aid in healing.
- Device Description: The description details metal plates and screws designed to be surgically implanted into the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The Stryker® XXL Volar Distal Radius Plates are a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
Homedica Osteonics is extending the Variax Distal Radius Plates of the Variax Distal Radius Plating System to include XXL sized plates as well as to modify the indications for use for the XXL Volar Distal Radius Plates to include Osteotomies, non-unions and mal-unions.
Each plate will accept a locking screw, bone screws, locking pegs, and partially threaded screws. The XXL plates are precontoured performed for palmer, fixation. Screws are selftapping and have either cross-pin or torx heads.
Plates are offerered in 5,8,11,and 15 hole options with a 2mm distal profile height and 3mm profile shaft height. All plates are straight and pre-contoured to fit the radial bow beyond the shaft. Gliding holes all for allignment of the plate and allow for additional bone reduction if required.
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)
Based upon the mechanical testing, the VariAx Distal Radius Line Extension of XXL Plates is substantially equivalent for its intended use to other plating systems currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K100271 (1/2)
MAY 1 4 2010
510(k) Summary of Safety and Effectiveness
| Proprietary Name: | VariAx Distal Radius Line Extension of XXL Plates |
|---|---|
| Common Name: | Bone plates and screws |
| Classification Name and Reference: | Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030 |
| Regulatory Class: | Class II |
| Product Codes: | HRS: Plate, Fixation, Bone |
| For Information contact: | Melissa Matarese, Regulatory Affairs Associate |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5116 Fax: (201) 831-4116 | |
| Date Prepared: | October 20, 2009 |
Description:
Homedica Osteonics is extending the Variax Distal Radius Plates of the Variax Distal Radius Plating System to include XXL sized plates as well as to modify the indications for use for the XXL Volar Distal Radius Plates to include Osteotomies, non-unions and mal-unions.
Each plate will accept a locking screw, bone screws, locking pegs, and partially threaded screws. The XXL plates are precontoured performed for palmer, fixation. Screws are selftapping and have either cross-pin or torx heads.
Plates are offerered in 5,8,11,and 15 hole options with a 2mm distal profile height and 3mm profile shaft height. All plates are straight and pre-contoured to fit the radial bow beyond the shaft. Gliding holes all for allignment of the plate and allow for additional bone reduction if required.
Intended Use:
The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and
1
extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.
Indications:
The indications for use of The Stryker® XXL Volar Distal Radius Plates include:
The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.
Substantial Equivalence:
The VariAx Distal Radius Line Extension of XXL Plates is substantially equivalent to other commercially available plate systems in regard to intended use, design materials and operational The following devices are examples of predicate systems: Stryker Leibinger principles. Universal Distal Radius System (K040022) which is marketed under the name of VariAx Distal Radius System, Synthes Diaphyseal-Metaphyseal Volar Distal Radius Plate (K070946), and Zimmer Periarticular Locking Plate System (K040593). Based upon the mechanical testing, the VariAx Distal Radius Line Extension of XXL Plates is substantially equivalent for its intended use to other plating systems currently on the market. Also, the Distal Radius Torx Screws are compatible with this system (K080667).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 4 2010
Howmedica Osteonics Corporation % Ms. Melissa Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New-Jersey-07430
Re: K100271
Trade/Device Name: VariAX Distal Radius Line Extension of XXL Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 29, 2010 Received: April 30, 2010
Dear Ms. Matarese:
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. Iisting 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. Melissa Matarese
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/CDRH/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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark M. Millers
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): | | 0027 |
Device Name: VariAx Distal Radius Line Extension of XXL Plates
Indications for Use:
The indications for use of the Distal Radius System:
The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.
Over-The-Counter Prescription . Use X Use - AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ooutu of mxa
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100271