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The femoral nail is indicated for use in a variety of femoral fractures, such as:

• Subtrochanteric Fractures
• Intertrochanteric Fractures
• Comminuted Fractures
• Segmental Fractures
• Fractures with Bone Loss
• Proximal and Distal Fractures
• Nonunions

The retrograde femoral nail is indicated for use in a variety of retrograde type femoral fractures, such as:

• Closed Supracondylar Fractures
• Severely Comminuted Supracondylar Fractures with Articular Involvement
• Nonunions or Pseudoarthroses
• Malunions
• Pathological Fractures
• Fractures without Extensive Comminution
• Distal Fractures Involving Osteoporotic Bone
• Fractures Involving the Femoral Condyles that Require Open Knee Access
• T-Condylar Fractures
  – Femoral Shaft Fracture with Attendant Femoral Neck Fractures (Nail to be Used in Conjunction with Fixation Screws or Plates as Needed)
• Intertrochanteric Femoral Shaft Fractures
• Ipsilateral Femorotibial Fractures ("Floating Knee" Fractures)
• Femoral Shaft Fractures
• Bilateral Femoral Shaft Fractures
• Ipsilateral Patellofemoral Fractures

The tibial nail is indicated for use in a variety of tibial fractures, such as:

• Comminuted Fractures
• Segmental Fractures
• Fractures with Bone Loss
• Proximal and Distal Fractures
• Nonunions
• Transverse Fractures
• Oblique Fractures
• Spiral Fractures
• Bilateral Fractures
• Fractures with Butterfly Fragments
• Pseudarthrosis of the Tibial Shaft
• Corrective Osteotomies

The humeral nail is indicated for use in a variety of humeral fractures, such as:

• Comminuted Fractures
• Segmental Fractures
• Fractures with Bone Loss
• Proximal and Distal Fractures
  — Nonunions
• Delayed Unions
• Pathological Fractures
• Floating Elbow
  – Nerve Lesion
• Multiple Trauma Injuries

This submission covers line extensions and labeling changes to the Zimmer M/DN Intramedullary Fixation System. The Zimmer M/DN Intramedullary Fixation System is used for closed nailing of femoral, tibial, and humeral shaft fractures and includes femoral nails, retrograde femoral nails, tibial nails, humeral nails, self-tapping interlocking screws, nail caps, and cortical nuts. The nails are cannulated stainless steel rods with proximal and distal holes for insertion of interlocking screws.

This document is a 510(k) premarket notification for the Zimmer M/DN Intramedullary Fixation System. It does not describe an AI medical device or a study proving its performance against acceptance criteria. Instead, it is a regulatory submission for a physical medical device (intramedullary fixation rods) and focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI device. The document explicitly states: "Clinical data and conclusions were not needed for these devices to show substantial equivalence."

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