(105 days)
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.
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.
This K100271 document is a 510(k) Summary of Safety and Effectiveness for the VariAx Distal Radius Line Extension of XXL Plates. It describes a medical device (bone plates and screws) and seeks to demonstrate its substantial equivalence to existing devices.
The document does not contain information about software, AI, or diagnostic performance studies. Instead, it focuses on the mechanical and design equivalence of bone plates and screws. Therefore, it does not provide the specific details requested for acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies that would be relevant for a diagnostic or AI-based device.
Based on the provided text, here's what can be extracted and a clear statement of what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not describe acceptance criteria or reported device performance in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) or human reader improvement for an AI system. Instead, the "performance" discussed is related to the mechanical properties and design of the bone plates to establish substantial equivalence.
| Item Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Design Equivalence | Substantially equivalent to predicate devices in intended use, design, materials, and operational principles, and for its intended use. | Based upon 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." |
2. Sample size used for the test set and the data provenance
Not applicable. This document refers to mechanical testing for bone plates, not a test set for a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document refers to mechanical testing for bone plates, not ground truth for a diagnostic algorithm.
4. Adjudication method for the test set
Not applicable. This document refers to mechanical testing for bone plates, not a test set for a diagnostic algorithm.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This document describes bone plates and screws, not an AI-assisted diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This document describes bone plates and screws, not an AI algorithm.
7. The type of ground truth used
Not applicable. This document refers to mechanical testing for bone plates, not ground truth for a diagnostic algorithm. The "ground truth" for mechanical testing would implicitly be the established mechanical engineering standards and performance of the predicate devices.
8. The sample size for the training set
Not applicable. This document describes bone plates and screws, not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This document describes bone plates and screws, not an AI algorithm.
In summary, the provided document K100271 pertains to the regulatory submission for a physical medical device (bone plates and screws) and primarily establishes substantial equivalence based on mechanical testing and design attributes. It does not involve any AI, software, or diagnostic performance claims that would necessitate the types of studies and criteria outlined in the input request.
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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 AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (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
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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
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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
§ 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.