(64 days)
Synthes Distal Radius Plate System is intended for fixation of fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspect.
The Distal Radius Plate System consists of volar and dorsal plates, 2.4 mm cortex screws, and 1.8 mm threaded-head buttress pins. The volar plate is T-shaped, precontoured, and has six threaded screw holes. The dorsal plate is shaped like the Greek letter Pi, precontoured, and has six internally threaded screw holes in the head. Both plates are available in right and left versions; accept cortex screws (2.7 mm and 2.4 mm) and 1.8 mm threaded-head buttress pins; and can be cut to size.
The provided text is a 510(k) Summary for the Synthes (USA) Distal Radius Plate System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a formal study with detailed statistical outcomes.
Therefore, the document does not contain the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes, provenance of data, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results.
The document primarily focuses on:
- Device Description: The physical characteristics of the plates and screws.
- Intended Use: Fixation of fractures and osteotomies involving the distal radius.
- Material: Stainless Steel and Titanium alloy for plates, Titanium and Stainless Steel for screws.
- Predicate Devices: Synthes Dorsal Distal Radius Plate System (K962616) and Synthes Ti Alloy Volar Distal Radius Plate System (K963798).
The FDA's letter (K982732) confirms that the device is substantially equivalent to legally marketed predicate devices, which allows it to be marketed. This regulatory pathway does not typically involve the detailed study design and acceptance criteria reporting you've outlined.
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Attachment VII:
SUBMITTER
Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Sheri L. Musgnung
COMMON OR USUAL NAME
Screw, Fixation, Bone Plate, Fixation, Bone
DEVICE CLASSIFICATION: Class II, 21 CFR 888.3030; 888:3040
Synthes Dorsal Distal Radius Plate System (K962616) PREDICATE DEVICE: Synthes Ti Alloy Volar Distal Radius Plate System (K963798)
The Distal Radius Plate System consists of volar and dorsal DESCRIPTION: plates, 2.4 mm cortex screws, and 1.8 mm threaded-head buttress The volar plate is T-shaped, precontoured, and has six pins. threaded screw holes. The dorsal plate is shaped like the Greek letter Pi, precontoured, and has six internally threaded screw holes in the head. Both plates are available in right and left versions; accept cortex screws (2.7 mm and 2.4 mm) and 1.8 mm threaded-head buttress pins; and can be cut to size.
Synthes Distal Radius Plate System is intended for fixation of INTENDED USE: fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspect.
| MATERIAL: | Plates: Stainless Steel and Titanium alloy |
|---|---|
| Screws: Titanium and Stainless Steel |
Synthes (USA) Distal Radius Plate System 510(k) CONFIDENTIAL
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 1998
Ms. Sheri L. Musqnung Requlatory Affairs Specialist Synthes USA 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K982732 Synthes (USA) Distal Radius Plate System Regulatory Class: II Product Codes: HRS and HWC Dated: August 4, 1998 Received: August 5, 1998
Dear Ms. Musgnung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference fo
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use Statement
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K982732
Device Name: Synthes (USA) Distal Radius Plate System
Indications For Use:
Synthes Distal Radius Plate System is intended for fixation of fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspect.
(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 _________________________________________________________________________________________________________________________________________________________
Acsellaz
(Divisi Sign-Off Division of General Restorative Devices 510(k) Number
Synthes (USA) Distal Radius Plate System 510(k) 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.