# K232693: Tyber Medical Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Dec 4, 2023 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: 17 generations back to K954385 (1996). 250 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 252 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203817: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2021). Our OCR of the scanned summary read K203871, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Tyber Medical Anatomical Plating System”.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 4.
- K193222: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2020) Summary page 4.
- K222465: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2023) Summary page 4.

## Most influential descendants
- K251361: Tyber Medical Distal Radius Plating System (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K232693
Methodology: https://510kreport.com/methodology