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The Treu Bone Fixation Screws and Pins are intended to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.

Treu Bone Screws are available in thread diameters ranging from ø1.5 mm to ø7 mm, lengths ranging from 6 mm to 130 mm, are either cannulated or non-cannulated and made of stainless steel or titanium alloy.

Treu Schanz Screws are available in wire diameters ranging from ø3.0 mm to ø6.0 mm, lengths ranging from 60 mm to 350 mm, thread lengths ranging from 20 mm and are made of stainless steel.

Treu Kirschner Wires are available in wire diameters ranging from ø0.8 mm to ø3.0 mm, lengths ranging from 70 mm to 500 mm, are partially or completely smooth or threaded and are made of stainless steel.

Treu Steinmann Pins are available in wire diameters ranging from ø3.0 mm to ø6.0 mm, lengths ranging from 80 mm to 500 mm, are partially or completely smooth or threaded and are made of stainless steel.

Treu Larsen Pins are available in one diameter (ø1.6 mm) and four lengths (60, 80, 100, 120 mm). The head of the pin is 2.5 mm thick and the anchoring hole is ø1.2 mm to facilitate a ø1 mm cerclage wire. The proximal part of the Larsen Pin is prepared for cutting and fits in conventional as well as mini drivers.

The provided document is a 510(k) summary for Treu Bone Fixation Screws and Pins. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study with detailed results as often seen with AI/software as a medical device (SaMD) or novel device submissions.

Therefore, the document does not contain the following information typically associated with a study proving acceptance criteria for AI medical devices:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).

Instead, the submission demonstrates substantial equivalence based on:

1. Device Description: Detailed specifications of the Treu Bone Fixation Screws and Pins (materials, dimensions, cannulated/non-cannulated, smooth/threaded).
2. Intended Use: Clearly states the intended use as implants for fixation of bone fractures, fusion of joints, bone reconstructions, or as guide pins for insertion of other implants.
3. Substantial Equivalence to Predicate Devices: Lists several existing legally marketed devices (K983006, K021932, K062103, etc.) from manufacturers like Stryker, Synthes, Darco, DePuy, OsteoMed, and Störk Instrumente. The conclusion states that the Treu devices are substantially equivalent to these predicate devices based on the available information.

In summary, this 510(k) submission for Treu Bone Fixation Screws and Pins relies on demonstrating that the device is as safe and effective as other devices already on the market through substantial equivalence, rather than providing the detailed clinical study information requested for acceptance criteria proof, which is more common for novel technologies or AI/SaMD.

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