(71 days)
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No
The summary describes a mechanical external fixator clamp and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device, an external fixator clamp, is used in the construction of an external fixation frame for the treatment of long bone fractures, which is a therapeutic intervention.
No
The device description indicates it is a component for an external fixation frame used in treating bone fractures, which is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is manufactured from titanium alloys, indicating it is a physical 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 construction of an external fixation frame for treating long bone fractures. This is a surgical/orthopedic device used directly on the patient's body.
- Device Description: The device is a physical clamp made of titanium alloy.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not interact with or analyze biological specimens.
The information provided clearly describes a surgical implant/device used for mechanical support and stabilization of bone fractures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Synthes Ti External Fixator Clamps are used in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Ti External Fixator Clamps are manufactured from Titanium-6% Niobium (Ti-6A1-7Nb) or a Titanium-6% Aluminum-4% Vanadium (Ti-6A1-4V) alloy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
long bone fractures
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)
Based on the mechanical properties for the Ti-6A1-7Nb material, the External Fixator Clamps will perform at least equivalent to Ti-6Al-4V External Fixator Clamps.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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 a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A small registered trademark symbol is located to the right of the word.
5 1996