(68 days)
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."
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.