(88 days)
Not Found
Not Found
No
The summary describes a traditional metal plate for surgical fixation and makes no mention of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
Yes.
The device's intended use is to promote fusion or "arthrodesis" of the ankle, which is a treatment for a medical condition.
No
This device is a plate for surgical fixation (arthrodesis) of the ankle, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "minimally contoured metal plate," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Synthes Ankle Arthrodesis Plate is a physical implant (a metal plate and screws) used for surgical fixation to promote bone fusion. It is used in the body, not to test samples from the body.
- Intended Use: The intended use is for arthrodesis (fusion) of the ankle and distal tibia, which is a surgical procedure, not a diagnostic test.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Synthes Ankle Arthrodesis Plate is intended for arthrodesis of the ankle and the distal tibia.
Product codes
HRS
Device Description
The Synthes Ankle Arthrodesis Plate is a minimally contoured metal plate that utilizes traditional internal plate/screw fixation to promote fusion or “arthrodesis” of the ankle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, distal tibia
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)
Not Found
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.
0
K013415
page 1 of 1
Summary of Safety and Effectiveness Information 3.
JAN 11 2002
| Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 | JAN 11 2002 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Company Contact | Matthew M. Hull
(610) 647-9700 ext. 7191 | |
| Name of the Device | Synthes Ankle Arthrodesis Plate | |
| Device Classification(s) | Class II, §888.3030 - Plate, Fixation, Bone | |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes Ankle
Arthrodesis Plate to be substantially equivalent to another legally
marketed device. | |
| Device Description | The Synthes Ankle Arthrodesis Plate is a minimally contoured metal
plate that utilizes traditional internal plate/screw fixation to promote
fusion or “arthrodesis” of the ankle. | |
| Indications | The Synthes Ankle Arthrodesis Plate is intended for arthrodesis of the
ankle and the distal tibia. | |
| Materials | Stainless Steel | |
CONFIDENTIAL
:
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 an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2002
Mr. Matthew M. Hull, RAC Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K013415
Trade/Device Name: Synthes Ankle Arthrodesis Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: October 12, 2001 Received: October 15, 2001
Dear Mr. Hull:
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 - Mr. Matthew M. Hull, RAC
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 and additionally 21 CFR Part 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" (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,
Stupt Rhodes
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
page 1 of 1
Indications for Use Statement 2.
510(k) Number (if known):
Device Name:
Indications for Use:
KOI 3415
Synthes Ankle Arthrodesis Plate
The Synthes Ankle Arthrodesis Plate is intended for arthrodesis of the ankle joint and distal tibia.
(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_
Stytk Pluorlu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KU13415 510(k) Number -
Synthes(USA) Synthes Ankle Arthrodesis Plate 510(k) CONFIDENTIAL