(30 days)
Not Found
Not Found
No
The description focuses on mechanical adjustment and does not mention any computational or learning capabilities.
Yes
The device is described as "intended for stabilizing fractures of the distal radius," which is a therapeutic function.
No
Explanation: The device is described as an "external wrist fixator" intended for "stabilizing fractures of the distal radius," which indicates a therapeutic or stabilizing function rather than one that diagnoses a condition.
No
The device description explicitly states it is a "pre-assembled mechanically adjustable external wrist fixator" consisting of "plastic and metal components" and is applied to bone with "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, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical external fixator applied to bone. This is a surgical/orthopedic device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances in these samples to diagnose a condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a surgical implant/external fixator used to physically stabilize a fracture.
N/A
Intended Use / Indications for Use
Synthes Sterile Adjustable Distal Radius Fixator (ADRF) is intended for fixation of the distal radius.
Synthes Sterile Adjustable Distal Radius Fixator System is intended for stabilizing fractures of the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
KTT, HWC
Device Description
The Sterile Adjustable Distal Radius Fixator is a pre-assembled 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 operates by turning screws, which operate gears, to achieve incremental movement.
The sterile packaged ADRF is packaged with Synthes 4.0 mm/3.0 mm stainless steel, self-drilling Schanz screws or Synthes 4.0 mm/3.0 mm titanium self-drilling Schanz Screws.
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 (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.
Not Found
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.
0
NOV 26 2003
K033411
page 1 of 1
3. Summary of Safety and Effectiveness Information [510(k) Summary]
| Submitter: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Bonnie Smith
(610) 647-9700 |
| Name of the Device: | Synthes (USA)
Sterile Adjustable Distal Radius Fixator (ADRF) with
4.0 mm/3.0 mm Self-Drilling Schanz Screws |
| Classification: | Class II, 21 CFR 888.3030 and 888.3040 |
| Common or Usual Name: | External Fixation Frame |
| Predicate (unmodified) Device: | Synthes (USA)
Articulating ("Adjustable") Distal Radius Fixator (ADRF) |
| Device Description: | The Sterile Adjustable Distal Radius Fixator is a pre-
assembled 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 operates by turning screws, which operate gears,
to achieve incremental movement.
The sterile packaged ADRF is packaged with Synthes
4.0 mm/3.0 mm stainless steel, self-drilling Schanz screws or
Synthes 4.0 mm/3.0 mm titanium self-drilling Schanz Screws. |
| Intended Use: | Synthes Sterile Adjustable Distal Radius Fixator (ADRF) is
intended for fixation of the distal radius. |
| Material: | Polyetherimide, stainless steel, and titanium alloy |
| Substantial Equivalency: | Documentation is provided which demonstrates that the
Synthes Sterile Adjustable Distal Radius Fixator is
substantially equivalent to its predicate device. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing health and well-being.
NOV 26 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K033411
Trade/Device Name: Synthes Sterile Adjustable Distal Radius Fixator (ADRF) Regulation Numbers: 21 CFR 888.3030 and 888.3040 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, and Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: KTT and HWC Dated: October 24, 2003 Received: October 27, 2003
Dear Ms. Smith:
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.
2
Page 2 - Ms. Bonnie J. Smith
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,
for 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
3
2. Indications for Use
Special 510(k) Device Modification
INTENDED USE STATEMENT
03341
510(k) Number (if known):
Device Name:
Indications:
Synthes Sterile Adjustable Distal Radius Fixator (ADRF)
Synthes Sterile Adjustable Distal Radius Fixator System is intended for stabilizing fractures of the distal radius.
fo Mark N. Milhurn
ivision Sign-Off) Division of General. Restorative and Neurological Levices
K033411 "10(k) Number_________________________________________________________________________________________________________________________________________________________________
(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
Synthes (USA) Special 510(k): Synthes Sterile ADRF 000004