# K142442: Magna-FX and Mini Magna-FX Cannulated Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 3, 2014 after 31 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962616 (1996). 66 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111994: Smith & Nephew Cannulated Screws and Washers, Smith & Nephew, Inc. (2011) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.

## Most influential descendants
- K150693: PHIN-FX Cannulated Lag Screw System (2015), 9 descendants of its own
- K161904: GEO Bone Screw System (2017), 4 descendants of its own
- K143702: Arthrex Blunt Tip Screws with Fiber Tape (2015), 4 descendants of its own
- K163489: OrthoSolutions 'System26' Bone Screws (2017), 3 descendants of its own
- K201677: Arthrex Mesh Plates (2020), 2 descendants of its own

## Recalls of this device
- May 4, 2016 · Class II · Z-1679-2016: 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-1142-2016: 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-1144-2016: 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 Magna-FX Cannulated Bone Screws are indicated for fractures of: • The intracapsular hip, femoral condyles, tibial condyles, ankle, acetabulum, pelvis, and other areas where accurate screw placement is required. • The screw can also be applied to slipped capital femoral epiphysis if image intensification fluoroscopy is used to ascertain the proper position of the screw. The Mini Magna-FX Cannulated Bone Screws are indicated for: • Fractures of the medial malleolus, distal tibia, distal radius, calcaneus, talus, patella, and pelvis. • It can also be used in the reduction of small bone fragments and reduction and fixation with cerclage wire, and the fixation of bone prominences.

Source page: https://510kreport.com/device/K142442
Methodology: https://510kreport.com/methodology