# K122310: Geminus Fossa Specific Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, LLC
- Decided: Jan 18, 2013 after 170 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: 8 generations back to K962616 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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 1.
- K122737: Geminus Fossa Specific Plate System, Skeletal Dynamics, LLC (2012). Cleared while this submission was under review Summary page 1.
- K963798: Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System, Synthes (Usa) (1996) Summary page 1.
- K951303: SFC, Medpac (1995) Summary page 1.

## 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/K122310
Methodology: https://510kreport.com/methodology