# K142281: Zimmer M/DN Intramedullary Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 22, 2014 after 68 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K970097 (1997). 10 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962561: Supracondylar Intramedullary Nail, Zimmer, Inc. (1996) Summary page 5.
- K965098: Intramedullary Nail System, Zimmer, Inc. (1997) Summary page 5.
- K101622: Zimmer Natural Nail System Retrograde Femoral Nails, Zimmer, Inc. (2010) Summary page 5.

## Most influential descendants
- K181827: Affixus Natural Nail System Humeral Nail (2018), 6 descendants of its own
- K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (2023), 4 descendants of its own
- K241651: Affixus Tibial and Antegrade Femoral Nailing System (2024), 2 descendants of its own
- K200814: Affixus (R) Natural Nail (R) System Humeral Nail (2020), 1 descendant of its own
- K253566: Affixus Retrograde Femoral Nailing System (2026), 0 descendants of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0328-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Apr 28, 2017 · Class II · Z-2595-2017: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
- Apr 28, 2017 · Class II · Z-2597-2017: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
- Apr 28, 2017 · Class II · Z-2598-2017: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
- May 4, 2016 · Class II · Z-1678-2016: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Jan 11, 2016 · Class II · Z-1136-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1141-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

## Indications for use
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

Source page: https://510kreport.com/device/K142281
Methodology: https://510kreport.com/methodology