(72 days)
Not Found
Not Found
No
The summary describes a mechanical clamp for external fixation and makes no mention of AI or ML.
Yes
The device is described as being used in the "treatment of long bone fractures that require external fixation," which indicates a therapeutic purpose.
No
Explanation: The device, the Synthes Ti Tube to Tube Clamp, is explicitly stated to be "intended for use in the construction of an external fixation frame for the treatment of long bone fractures." This describes a therapeutic, rather than a diagnostic, function. There is no mention of it acquiring, processing, or analyzing data to identify a disease, condition, or its characteristics.
No
The device description explicitly states it is manufactured from a Titanium Alloy and is a physical clamp used in external fixation frames, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Synthes Ti Tube to Tube Clamp is a mechanical device used externally on the body to stabilize bone fractures. It is part of an external fixation frame.
The description clearly states its purpose is for constructing an external fixation frame for treating long bone fractures. This is a surgical/orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Synthes Ti Tube to Tube Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the two carbon fiber rods or stainless steel tubes.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The clamps attach the two carbon fiber rods or stainless steel tubes. The device is manufactured from a Titanium Alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone fractures
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)
Based on mechanical test results, the Ti Tube to Tube Clamp has been found to be substantially equivalent to the Articulation Coupler.
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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 registered trademark symbol is located to the right of the word.
MAY -8 1996
Attachment VII:
Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
(610) 647-9700 Contact: Angela J. Silvestri February 22,1996
Synthes Ti Tube to Tube Clamp is compared to Ace Medical's Articulation Coupler.
Synthes Ti Tube to Tube Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the two carbon fiber rods or stainless steel tubes. The device is manufactured from a Titanium Alloy.
Ace Medical's Articulation Coupler is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the two rods. The clamps attach the two carbon fiber rods or stainless steel tubes. The device is manufactured from a Titanium Alloy.
Based on mechanical test results, the Ti Tube to Tube Clamp has been found to be substantially equivalent to the Articulation Coupler.