(60 days)
Not Found
Not Found
No
The summary describes a mechanical implant (metal plates and screws) for ankle fusion and makes no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is intended for arthrodesis (fusion) of the ankle joint, which is a therapeutic intervention to treat a medical condition.
No
The device is described as metal plates used to promote fusion of the ankle joint, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "minimally contoured metal plate" and will be offered in "stainless steel and commercially pure titanium," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- The Synthes LCP Ankle Arthrodesis Plates are surgical implants used to fuse bones in the ankle. They are physically placed within the body and do not analyze biological samples.
The provided information clearly describes a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
Synthes LCP Ankle Arthrodesis Plates are minimally contoured metal plates that utilize locking screw technology to promote fusion or "arthrodesis" of the ankle. The plates will be offered in stainless steel and commercially pure titanium and will be available in sterile and non-sterile versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle joint and 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): 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 Ankle Arthrodesis Plates
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
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold black letters with a registered trademark symbol. To the right of the word is the code "Ko61940 (fg 1 of i)" in handwritten-style font. A black line is present underneath the word "SYNTHES".
3.0 510(k) Summary
Page _________ of __1
| Sponsor: | Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-6940 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes LCP Ankle Arthrodesis Plate |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone
fixation appliances and accessories. |
| Predicate Device: | Synthes Ankle Arthrodesis Plates |
| Device Description: | Synthes LCP Ankle Arthrodesis Plates are minimally contoured
metal plates that utilize locking screw technology to promote
fusion or "arthrodesis" of the ankle. The plates will be offered in
stainless steel and commercially pure titanium and will be available
in sterile and non-sterile versions. |
| Intended Use: | Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis
of the ankle joint and distal tibia. |
| Substantial Equivalence: | Information presented supports substantial equivalence. |
1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
:
:
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2006
Synthes (USA) % Ms. Sheri L. Musgnung Sr. Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K061940 Trade/Device Name: Synthes LCP Ankle Arthrodesis Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 7, 2006 Received: July 10, 2006
Dear Ms. Musgnung:
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. Sheri L. Musgnung
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 (240) 276-0120 . 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/industry/support/index.html.
Sincerely yours.
Barbara Buchup
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized image of a person's head. There is a horizontal line below the word "SYNTHES".
| 2.0 | Indications for Use |
|---|---|
| 510(k) Number (if known): | K061940 |
| Device Name: | Synthes LCP Ankle Arthrodesis Plates |
| Indications for Use: | |
| Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia. | |
| Prescription Use | X |
| (Per 21 CFR 801.109) | AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Barbara Buchholz |
Sources Such (Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(1) Number_Kloke 1940______________________________________________________________________________________________________________________________________________________
090004
: