(76 days)
The Synthes (USA) Small Titanium Wrist Fusion Plate is intended for use in plate fixation for wrist arthrodesis in patients with disorders such as cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. This plate addresses the smaller stature and pediatric patient by having a low profile construct and utilizing small screws.
The Synthes small titanium wrist fusion plate is a low profile plate with a 2.1 mm thickness, a proximal width of 8mm and a distal width of 6 mm. The plate uses a total of 8 holes across the 107 mm pre-contoured length. There are proximal and distal holes which utilizes 2.7 mm and 2.4mm screws. Limited contact undercuts are included to minimize plate to bone contact and the ends are tapered in thickness for minimal soft tissue irritation.
This submission is from 2003, and the provided text for K023879 does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document is primarily a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than detailed performance study results against specific acceptance criteria.
Therefore, I cannot provide the requested information from the text provided. The document outlines the device description, intended use, material, and classification, along with the predicates. It doesn't include:
- A table of acceptance criteria and the reported device performance.
- Sample size, data provenance, number of experts, adjudication method, or ground truth for a test set.
- Whether a MRMC comparative effectiveness study was done.
- Whether a standalone performance study was done.
- Sample size for the training set or how ground truth for it was established.
Medical device submissions, particularly older ones like this 510(k), often do not publicly disclose the detailed performance data and acceptance criteria in the summary document. These details are typically part of the full submission reviewed by the FDA but are not always part of the public-facing summary or clearance letter, especially when substantial equivalence is proven through design similarities, material biocompatibility, and intended use comparison, rather than extensive clinical performance studies.
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FEB 0 5 2003
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Summary of Safety and Effectiveness Information - 510(k) Summary 3.0
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | Small Titanium Wrist Fusion Plate |
| CLASSIFICATION: | Class II, § 888.3030 - Single / multiple component metallic bone fixationappliance and accessories |
| PREDICATE DEVICE: | Synthes Straight Wrist Fusion PlateBiomet® Colles Fracture Plate |
| DEVICE DESCRIPTION: | The Synthes small titanium wrist fusion plate is a low profile plate with a2.1 mm thickness, a proximal width of 8mm and a distal width of 6 mm.The plate uses a total of 8 holes across the 107 mm pre-contoured length.There are proximal and distal holes which utilizes 2.7 mm and 2.4mmscrews. Limited contact undercuts are included to minimize plate to bonecontact and the ends are tapered in thickness for minimal soft tissueirritation. |
| INTENDED USE: | The Synthes (USA) Small Titanium Wrist Fusion Plate is intended for usein plate fixation for wrist arthrodesis in patients with disorders such ascerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. Thisplate addresses the smaller stature and pediatric patient by having a lowprofile construct and utilizing small screws. |
| MATERIAL: | CP Titanium |
Confidential
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing health, services, and people. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2003
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) P. O. Box 1766 1690 Russell Road Paoli. Pennsylvania 19301
Re: K023879
Trade/Device Name: Synthes Small Titanium Wrist Fusion Plate Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: November 18, 2002 Received: November 21, 2002
Dear Ms. Boyle:
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
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Page 2 - Ms. Lisa M. Boyle
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in 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. 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). Other general information on your responsibilities under the Act may be obtained 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 Millman
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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2.0 Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known): | K023879 |
|---|---|
| Device Name: | Synthes (USA) Small Titanium Wrist Fusion Plate |
Indications/Contraindications:
The Synthes (USA) Small Titanium Wrist Fusion Plate is intended for use in plate fixation for wrist arthrodesis in patients with disorders such as cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. This plate addresses the smaller stature and pediatric patient by having a low profile construct and utilizing small screws.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
for Mark N Milkeran
(Division Sign-Off)
Confidential
§ 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.