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The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur include:

• · Compound and simple shaft fractures
• · Proximal, metaphyseal and distal shaft fractures
• · Segmental fractures
• · Comminuted fractures
• · Fractures involving osteopenic and osteoporotic bone
• · Pathological fractures
• · Fractures with bone loss
• · Pseudoarthrosis, non-union, mal-union and delayed union
• · Periprosthetic fractures
• · Surgically created defects such as osteotomies
• · Intertrochanteric and subtrochanteric fractures

The Zimmer Natural Nail System Antegrade Femoral Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired. All components are available in Ti-6Al-4V alloy.

This document is a 510(k) Premarket Notification for the Zimmer® Natural Nail™ System. It does not describe an AI/ML device or software that requires acceptance criteria based on performance studies.

Therefore, the prompt's request for information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not applicable to this document.

The document states:

• "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
• "Non-Clinical Performance and Conclusions: The results of non-clinical testing demonstrate that the devices are safe and effective."

This indicates that the device's safety and effectiveness were solely demonstrated through non-clinical testing, likely mechanical testing, material characterization, and comparison to predicate devices, rather than through clinical performance metrics involving human readers or AI algorithms.

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