(63 days)
Synthes Small T-Plate, Ace DePuy Symmetry Proximal Humerus Plate
Not Found
No
The summary describes a mechanical orthopedic plate for fracture fixation and does not mention any software, algorithms, or AI/ML components.
Yes
The device is described as being "intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia," which is a therapeutic purpose.
No
Explanation: The device, Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates, is described as being "intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia." This indicates a therapeutic or surgical function, not a diagnostic one. There is no mention of the device being used to identify, detect, or assess a medical condition.
No
The device description clearly describes a physical implant (plate) made of metal, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures and non-unions of the proximal humerus and distal tibia." This describes a surgical implant used to stabilize bones, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a surgical plate with features for bone fixation. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents, calibrators, or controls.
Therefore, the Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.
Product codes
KTW
Device Description
Synthes 3.5 mm 90° Cannulated LC-ABP provides stable fracture fixation and rotational control for fractures of the proximal humerus and distal tibia. The plates feature a low profile limited contact dynamic compression plate (LC-DCP®) design and dynamic compression unit (DCU) screw holes. The blade portion of the plate is cannulated to accept a 2.0 mm guide wire. The plates are available in various sizes to accommodate varying patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus 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)
Synthes Small T-Plate, Ace DePuy Symmetry Proximal Humerus Plate
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
Image /page/0/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 design inside. To the right of the word is a registered trademark symbol.
Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'k', followed by the numbers '992837'. The numbers are written in a simple, slightly slanted style, and the image has a clean, white background.
OCT 2 5 1999
3.0 Summary of Safety and Effectiveness Information
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Angela Silvestri |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates |
| CLASSIFICATION: | 21 CFR 888.3030 Single/multiple component metallic bone fixation
appliances and accessories. |
| PREDICATE DEVICE: | Synthes Small T-Plate
Ace DePuy Symmetry Proximal Humerus Plate |
| DEVICE DESCRIPTION: | Synthes 3.5 mm 90° Cannulated LC-ABP provides stable fracture fixation
and rotational control for fractures of the proximal humerus and distal tibia.
The plates feature a low profile limited contact dynamic compression plate
(LC-DCP®) design and dynamic compression unit (DCU) screw holes.
The blade portion of the plate is cannulated to accept a 2.0 mm guide wire.
The plates are available in various sizes to accommodate varying patient
anatomy. |
| INTENDED USE: | These plates are intended for the fixation of fractures and non-unions of the
proximal humerus and distal tibia. |
| MATERIAL: | Implant quality stainless steel and commercially pure titanium |
Confidential
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 1999
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
K992837 Re: Synthes (USA) 3.5mm 90° Cannulated Limited Contact Angled Blade Plates Requlatory Class: II Product Code: KTW Dated: Auqust 20, 1999 August 23, 1999 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 Requlations, Title 21, Parts 800 to 895. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 regulation (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,
Foll
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
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 registered trademark symbol is located to the right of the word.
2.0 Indications for Use Statement
Page of
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510(k) Number (if known):
Synthes (USA) 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates Device Name:
Indications/Contraindications:
Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992831
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Synthes (USA) 3.5 mm 90° Cannulated LC-ABP 510(k) Confidential