(63 days)
Not Found
No
The device description focuses on mechanical components and operation, with no mention of AI or ML terms, image processing, or data-driven performance metrics.
Yes
The device is described as an "Articulating Distal Radius Fixator System" intended for "stabilizing fractures of the distal radius," which clearly indicates a therapeutic purpose.
No
The device is described as a fixator system for stabilizing fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "preassembled mechanically adjustable external wrist fixator" consisting of "plastic and metal components" and is "applied to the bone with four self-drilling Schanz Screws". This clearly indicates a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "stabilizing fractures of the distal radius." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is an "external wrist fixator" applied to the bone with screws. This is a surgical/orthopedic device.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This device is clearly an external fixation device used in orthopedic surgery, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Synthes Distal Radius Plate System is intended for fixation of the distal radius.
Synthes Articulating Distal Radius Fixator System is intended for stabilizing fractures of the distal radius.
Product codes
KTT
Device Description
The Articulating Distal Radius Fixator is a preassembled mechanically adjustable external wrist fixator. It is a one-piece construct, which consists of plastic and metal components. The device is applied to the bone with four self-drilling Schanz Screws that lock into two fixator clamps. The device is operated by turning screws, which operates gears to achieve incremental movement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius, wrist
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes Simple Small External Fixatior (K963618), Hand Biomechanics Lab-Agee-WristJack (K942906), Biomet Inc, Hammer Mini-Tubular External Fixation Device (K982982)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 2/18/99 written in black ink. Below the date is the word "SYNTHES" in bold, black letters, with a registered trademark symbol to the right of the word. To the left of the word "SYNTHES" is a logo that appears to be a stylized image of a screw.
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| Attachment VI: | Summary of Safety and Effectiveness Information [510(k) Summary] |
|---|---|
| SUBMITTER | Synthes (USA) |
| 1690 Russell Road | |
| Paoli, PA 19301 | |
| (610) 647-9700 | |
| CONTACT: | Angela J. Silvestri |
| COMMON OR USUAL | |
| NAME: | External Fixation Frame |
| DEVICE | |
| CLASSIFICATION: | Class II, 21 CFR 888.3030; 888:3040 |
| PREDICATE DEVICE: | Synthes Simple Small External Fixatior (K963618) |
| Hand Biomechanics Lab-Agee-WristJack (K942906) | |
| Biomet Inc, Hammer Mini-Tubular External Fixation Device (K982982) | |
| DEVICE | |
| DESCRIPTION: | The Articulating Distal Radius Fixator is a preassembled |
| mechanically adjustable external wrist fixator. It is a one-piece | |
| construct, which consists of plastic and metal components. The | |
| device is applied to the bone with four self-drilling Schanz Screws | |
| that lock into two fixator clamps. The device is operated by turning | |
| screws, which operates gears to achieve incremental movement. | |
| INTENDED USE: | Synthes Distal Radius Plate System is intended for fixation of the |
| distal radius. | |
| MATERIAL: | Polyetherimide resin, stainless steel, and Ti-6A1-4V |
:
CONFIDENTIAL
:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1999
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K984498 Synthes (USA) Articulating Trade Name: Distal Radius Fixator Requlatory Class: II Product Code: KTT Dated: December 15, 1998 December 17, 1998 Received:
Dear Ms. Silvestri:
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 The general controls provisions of the Act 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. Angela J. Silvestri
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 requlation (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 to 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,
[signature]
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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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A small "R" in a circle is located to the right of the word, indicating a registered trademark.
2.0 Indications for Use Statement
Page of l 1
510(k) Number (if known):
Device Name: Synthes (USA) Articulating Distal Radius Fixator
Indications For Use:
Synthes Articulating Distal Radius Fixator System is intended for stabilizing fractures of the distal radius.
(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)
Over-The-Counter Use _ _ _ _ _ _ _ _
Pwolelo
(Division S gn-Off) Division of General Restorative Devices 9,94498 510(k) Number
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CONFIDENTIAL