(64 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) for bone fixation. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML medical devices.
No
This device is an orthopedic plate system used for fixation of fractures and osteotomies, rather than for therapeutic treatment.
No
The device, the Synthes Distal Radius Plate System, is an orthopedic implant used for fixation of fractures and osteotomies. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components like plates, screws, and pins, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Synthes Distal Radius Plate System is a system of plates, screws, and pins intended for the fixation of fractures and osteotomies in the distal radius. These are implantable devices used directly on the patient's bone.
- Intended Use: The intended use is for surgical fixation, not for analyzing biological samples.
Therefore, based on the provided information, the Synthes Distal Radius Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS and HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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)
Not Found
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.
Synthes Dorsal Distal Radius Plate System (K962616), Synthes Ti Alloy Volar Distal Radius Plate System (K963798)
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the date "OCT 8 1998" above the word "SYNTHES" in a bold, sans-serif font. To the left of the word "SYNTHES" is a logo that appears to be a stylized representation of a person. The logo and the word "SYNTHES" are the most prominent elements in the image.
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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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
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