(62 days)
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Not Found
No
The device description and intended use clearly describe a mechanical implant (a plate and screws) for bone fixation. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
This device is a plate intended for fixation of fractures, osteotomies, and carpal fusions, which is a structural implant rather than a therapeutic device.
No
The device is described as a plate for fixation of fractures, osteotomies, and carpal fusions. It is a surgical implant used for mechanical stabilization, not for diagnosing conditions.
No
The device description clearly states it is a physical plate made of titanium alloy, intended for surgical implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures, osteotomies, and carpal fusions involving the distal radius. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a metal plate and screws/pins designed for surgical implantation.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
Therefore, based on the provided information, the Synthes Dorsal Distal Radius Plate is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
Synthes Dorsal Distal Radius Plate is intended for fixation of fractures, osteotomies and carpal fusions involving the distal radius, applied to the dorsal aspect.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Synthes Dorsal Distal Radius Plate is PI shaped, with two proximal arms (shaft) and one distal arm (head). The plate is precontoured, and is available in right and left versions. The plate can be cut to size, and there are four compression holes and one round hole in each proximal arm (shaft) that accept 2.7 mm cortex screws, and seven internally threaded holes in the distal arm (head) that accept 1.8 mm threaded head buttress pins or 2.4 mm cortex screws.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
distal radius
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Synthes Dorsal Distal Radius Plate is at least equivalent to the Zimmer Small T-Plate, Oblique 人 based on the mechanical test results of both devices.
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.
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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/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 image inside. A small circle with a line through it is located to the right of the word.
K 962616
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (USA) 1690 Russell Road Paoli, PA 19301
ﺗﺸﺖ
(610) 647-9700 Contact: Angela Silvestri July 1996
Device: Synthes Dorsal Distal Radius Plate is compared to the Zimmer Small T-Plate, Oblique.
Synthes Dorsal Distal Radius Plate is intended for fixation of fractures, osteotomies and carpal fusions involving the distal radius, applied to the dorsal aspect. It is manufactured from a Titanium alloy.
Synthes Dorsal Distal Radius Plate is PI shaped, with two proximal arms (shaft) and one distal arm (head). The plate is precontoured, and is available in right and left versions. The plate can be cut to size, and there are four compression holes and one round hole in each proximal arm (shaft) that accept 2.7 mm cortex screws, and seven internally threaded holes in the distal arm (head) that accept 1.8 mm threaded head buttress pins or 2.4 mm cortex screws.
The Zimmer Oblique T-Plate is intended for condylar fixation.
Synthes Dorsal Distal Radius Plate is at least equivalent to the Zimmer Small T-Plate, Oblique 人 based on the mechanical test results of both devices.