# K190586: Monster® Screw System

- Pathway: 510(k) (Special)
- Applicant: Paragon 28, Inc.
- Decided: Apr 3, 2019 after 28 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: 13 generations back to K962616 (1996). 126 ancestors in all.
21 later devices descend from it; 6 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124027: Monster Screw System, Apogee Orthosolutions (2013) Summary page 5.
- K151418: Monster Screw System, Paragon 28 (2015) Summary page 5.
- K153378: Monster BITE Screw System, Paragon 28 (2015) Summary page 5.
- K162353: MICATM Screw System, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System, Extremity Medical, LLC (2017) Summary page 5.
- K142658: Biomet Headless Compression and Twist-off Screws, Biomet Manufacturing Corp (2014) Summary page 5.
- K101700: IO Fix Hand, IO Fix Foot, Extremity Medical Screw System, Extremity Medical, LLC (2010) Summary page 5.
- K123890: Acumed Cannulated Screw System, Acumed, LLC (2013) Summary page 5.

## Most influential descendants
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own
- K203011: Monster Screw System (2020), 6 descendants of its own
- K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System (2023), 4 descendants of its own
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own

## Indications for use
The Monster® Screw System 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. Specific examples include: Fractures and Osteotomies * Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc) * Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) * Talar fractures * Ankle fractures * Navicular fractures * Fractures of the fibula, malleolus, and calcaneus * Metatarsal and phalangeal osteotomies * Weil osteotomy * Calcaneal osteotomy Hallux Valgus Correction * Fixation of osteotomies (i.e. Akin, Scarf, Chevron) * Interphalangeal (IP) arthrodesis * Proximal, midshaft, or distal osteotomy * Lapidus arthrodesis Arthrodesis/Deformity Correction * 1st MTP arthrodesis * Metatarsal deformity correction * Tarsometatarsal joint arthrodesis * Naviculocuneiform joint arthrodesis * Talonavicular arthrodesis * Subtalar joint arthrodesis * Triple arthrodesis * Medial column arthrodesis * Subtalar joint distraction arthrodesis * Ankle arthrodesis * Lateralizing calcaneal osteotomy * Lateral column lengthening * Hammertoe Fusion resulting from neuropathic osteoarthropathy (Charcot) such as: * Medial and lateral column * Subtalar, talonavicular, and calcaneocuboid

Source page: https://510kreport.com/device/K190586
Methodology: https://510kreport.com/methodology