Search Results

Synthes (USA) LCP Wrist Fusion Plates are intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.

The Synthes LCP Wrist Fusion Plates are pre-contoured with a limited contact design utilizing a short bend with a 3.3 mm thickness and a width of 11 mm. The plate uses a total of 10 combination holes which utilizes 2.7 mm and 3.5 mm cortex and locking screws. The plates are available in Titanium and Stainless Steel.

The provided FDA 510(k) summary (K042355) for the Synthes (USA) LCP Wrist Fusion Plates indicates that this device received clearance based on substantial equivalence to a predicate device, the Synthes Straight Wrist Fusion Plate, 170 mm.

Therefore, the submission does not contain information about acceptance criteria for device performance based on a study of the new device itself, nor does it detail a study proving the device meets specific acceptance criteria as would be the case for a novel device or a device requiring clinical performance validation to demonstrate effectiveness.

Instead, the submission primarily focuses on demonstrating that the new device shares fundamental technological characteristics, intended use, and similar design features with an existing, legally marketed device. This type of submission relies on comparative data rather than performance criteria and study results for the new device.

Consequently, I cannot fill out the requested table and answer the study-specific questions, as the information is not present in the provided document. The document explicitly states: "Documentation is provided which demonstrates that Synthes LCP Wrist Fusion Plates are substantially equivalent to other legally marketed Synthes devices." The FDA's letter further confirms this by stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

Ask a specific question about this device