# K124027: Monster Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Apogee Orthosolutions
- Decided: Apr 5, 2013 after 98 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962616 (1996). 82 ancestors in all.
41 later devices descend from it; 6 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973309: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Vilex, Inc. (1998) Summary page 1.
- K991151: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw, Vilex, Inc. (1999) Summary page 1.
- K991197: Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24, Vilex, Inc. (1999) Summary page 1.
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 1.
- K924018: M3 Lag Screw Fixation System, Osteomed Corp. (1993) Summary page 1.
- K060428: CSS Cannulated Screw System, Orthohelix Surgical Designs, Inc. (2006) Summary page 1.
- K112885: Zimmer Plates and Screws System Screws Only, Zimmer, Inc. (2011) Summary page 1.
- K102903: Pioneer Cannulated Screw System, Pioneer Surgical Technology, Inc. (2010) Summary page 1.
- K060736: Smith & Nephew 6.5MM and 8.0MM Cannulated Screws, Smith & Nephew, Inc. (2006) Summary page 1.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 1.
- K111994: Smith & Nephew Cannulated Screws and Washers, Smith & Nephew, Inc. (2011)
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 1.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K012945: Synthes 2.4 MM Cannulated Screw, Synthes (Usa) (2001) Summary page 1.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 1.
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 1.
- K090949: Synthes (Usa) 1.5MM Headless Compression Screws, Synthes (Usa) (2009) Summary page 1.

## Most influential descendants
- K151418: Monster Screw System (2015), 27 descendants of its own
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System (2017), 24 descendants of its own
- K153378: Monster BITE Screw System (2015), 22 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K172617: Treace Medical Concepts (TMC) Compression Screw System (2017), 11 descendants of its own

## Indications for use
The Monster Screw SystemTM is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K124027
Methodology: https://510kreport.com/methodology