# K182492: Geminus Volar Distal Radius Plate System

- Pathway: 510(k) (Special)
- Applicant: Skeletal Dynamics, LLC
- Decided: Oct 10, 2018 after 29 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963798 (1996). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111620: Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right, Standard 3 Hole Left, Skeletal Dynamics, Skeletal Dynamics, LLC (2011) Summary page 4.
- K070946: Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates, Synthes (Usa) (2007) Summary page 4.

## Most influential descendants
- K202971: DRPx Locking Distal Radius Plate System (2021), 2 descendants of its own
- K252949: Geminus Volar Distal Radius Plating System (2025), 0 descendants of its own
- K251361: Tyber Medical Distal Radius Plating System (2025), 0 descendants of its own
- K233531: OIC FLEX-FIX™ System (2024), 0 descendants of its own
- K212601: DRPx Locking Distal Radius Plate System (2022), 0 descendants of its own

## Indications for use
The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius

Source page: https://510kreport.com/device/K182492
Methodology: https://510kreport.com/methodology