# K233423: Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Dec 21, 2023 after 72 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). 240 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 243 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) Summary page 4.
- K222465: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2023) Summary page 4.

## Cited in the summary but kept off the family tree
- K150999: Acclarix Diagnostic Ultrasound System, Edan Instruments, Inc. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K242486: Tyber Medical Anatomical Plating System (2025), 1 descendant of its own
- K261207: Exalta Proximal Tibia Plating System (2026), 0 descendants of its own

## Indications for use
Mini-Frag System: The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone including the hand, wrist, foot, and ankle. The mini-frag system is also intended for reduction and stabilization of non-load bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use.

Source page: https://510kreport.com/device/K233423
Methodology: https://510kreport.com/methodology