(65 days)
Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal or orthogonal application.
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The provided document is a 510(k) summary for the Stryker® Leibinger Universal Distal Radius System, a medical device for internal fixation of small bone fractures. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria for device performance.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Such studies, often involving clinical trials or performance testing with defined endpoints and statistical analyses, are typically submitted as part of the 510(k) application itself but are usually not detailed in the publicly available 510(k) summary.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size for a test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
The document primarily states the device's intended use and declares its substantial equivalence to predicate devices (K981283, K961496, and K014263). The substantial equivalence determination by the FDA implies that the new device is as safe and effective as a legally marketed device and does not require explicit proof of performance against new, separate acceptance criteria in the summary.
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MAR 1 2 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Stryker® Leibinger Universal Distal Radius System
page lot
| General Information | |
|---|---|
| Proprietary Name: | Stryker® Leibinger Universal Distal Radius System |
| Common Name: | Small Bone Plating System |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 87HRS (21 CFR 888.3030) Single/Multiple Component Metallic Bone Fixation Appliances and Accessories87LRN (21 CFR 888.3010) Bone Fixation cerclage |
| Submitter: | Stryker Leibinger4100 East Milham AvenueKalamazoo, MI 49001269-323-4226 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Wade T. RutkoskieAssociate Manager RA QAPhone: 269-323-4226Fax: 269-323-4215 |
| Summary Preparation Date: | January 5, 2004 |
Intended Use
Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal or orthogonal application.
SUBSTANTIAL EQUIVALENCY INFORMATION
The Stryker® Leibinger Universal Distal Radius System is substantially equivalent to legally marketed K981283 Rogachefsky Distal Radius Plates, K961496 Radius Reconstruction Plating System, and K014263 Universal Mandible System.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
MAR 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wade T. Rutkoskie Associate Manager, Regulatory Affairs and Quality Assurance Stryker Instruments, Leibinger Division 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K040022
Trade/Device Name: Stryker® Leibinger Universal Distal Radius System Regulation Numbers: 21 CFR 888.3030, 21 CFR 888.3010 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, Bone fixation cerclage Regulatory Class: II Product Codes: HRS, LR.N Dated: January 5, 2004 Received: January 7, 2004
Dear Mr. Rutkoskie:
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.
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 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); good manufacturing practice requirements as set 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.
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Page 2 - Mr. Wade T. Rutkoskie
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 (301) 594-4659. 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.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
. Mark N. Mellers
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Devicc Name: Stryker® Leibinger Universal Distal Radius System
Indication For Use:
Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include but are not limited to compression fractures, intra-articular and extraarticular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal or orthogonal application.
Mark H. Milliman
ral. Restorative, Division of Ge and Neurological Devices
510(k) Number K040022
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Or
Concurrence of CDRH, Office of device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109) X
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.