# K203011: Monster Screw System

- Pathway: 510(k) (Special)
- Applicant: Paragon 28, Inc.
- Decided: Nov 13, 2020 after 43 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: 14 generations back to K962616 (1996). 127 ancestors in all.
6 later devices descend from it; 6 cite it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190586: Monster® Screw System, Paragon 28, Inc. (2019) Summary page 5.

## Most influential descendants
- K251555: Ultra™ Compression Screw System (2025), 1 descendant of its own
- K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (2023), 1 descendant of its own
- K261647: Tempo Plating System; Ultra Compression Screw System (2026), 0 descendants of its own
- K241262: Baby Gorilla/Gorilla Plating System; Monster Screw System (2024), 0 descendants of its own
- K223184: Phantom Metatarsal Shortening System (2022), 0 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/K203011
Methodology: https://510kreport.com/methodology