# K251361: Tyber Medical Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Jul 30, 2025 after 90 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: 18 generations back to K954385 (1996). 264 ancestors in all.
No later device cites it as a predicate yet.
0 of 265 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232693: Tyber Medical Distal Radius Plating System, Tyber Medical, LLC (2023) Summary page 5.
- K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System, DePuy Synthes (2024) Summary page 5.
- K193554: APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System, Medartis AG (2020) Summary page 5.
- K182492: Geminus Volar Distal Radius Plate System, Skeletal Dynamics, LLC (2018) Summary page 5.

## Indications for use
The Tyber Medical Distal Radius Plating System includes Distal Radius, Forearm, and Fragment-Specific Plates, which are indicated for fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand. The Tyber Medical Distal Radius Plating System is not for spinal use.

Source page: https://510kreport.com/device/K251361
Methodology: https://510kreport.com/methodology