(13 days)
Not Found
No
The summary describes a traditional metal plate for surgical fixation and makes no mention of AI or ML.
Yes
The device is intended for arthrodesis (fusion) of the ankle joint, which is a therapeutic procedure to treat conditions like arthritis or instability.
No
The device description states its purpose is for "arthrodesis of the ankle joint and distal tibia" and to "promote fusion or 'arthrodesis' of the ankle," which are therapeutic functions, not diagnostic.
No
The device description clearly states it is a "minimally contoured metal plate" and utilizes "traditional internal plate/screw fixation," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arthrodesis of the ankle joint and distal tibia," which is a surgical procedure to fuse bones. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as "minimally contoured metal plates that utilize traditional internal plate/screw fixation." This is a physical implant used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status. The provided description does not mention any such use or interaction with biological specimens.
Therefore, the Synthes Ankle Arthrodesis Plates are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.
Product codes
HRS
Device Description
The Synthes Ankle Arthrodesis Plates are minimally contoured metal plates that utilize 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)
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
JUL 2 5 2002
022255
page 1 of 1
3. 510(k) Summary:
510(k) SUMMARY
| Submitter: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Matthew M. Hull
(610) 647-9700 |
| Name of the Device: | Synthes (USA) Ankle Arthrodesis Plates |
| Classification: | Class II, 21 CFR 888.3030 |
| Common or Usual Name: | Plate, Fixation, Bone, Non-spinal |
| Predicate (unmodified) Device: | Synthes Ankle Arthrodesis Plates, K013415 |
| Device Description: | The Synthes Ankle Arthrodesis Plates are minimally
contoured metal plates that utilize traditional internal
plate/screw fixation to promote fusion or "arthrodesis" of
the ankle. |
| Intended Use: | The Synthes Ankle Arthrodesis Plates are intended for
arthrodesis of the ankle and the distal tibia. |
| Material: | Stainless Steel |
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three faces in profile, suggesting a sense of community and care.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD: 20850
JUI 2 5 2002
Mr. Matthew M. Hull. RAC Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road PO Box 1766 Paoli. Pennsylvania 19301
Re: K022255
Trade/Device Name: Synthes Ankle Arthrodesis Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 9. 2002 Received: July 12, 2002
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
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,
Mark M. Millenson
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
510(k) Number (if known):
Device Name:
Indications
Synthes Ankle Arthrodesis Plates
The Synthes Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.
(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
Mark A. Wilkerson
- Recond stime and Neurologi
510(k) Number K022235
Synthes (USA) CONFIDENTIAL Special 510(k): Synthes Ankle Arthrodesis Plates
0,00004
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