# K241218: Tyber Medical Anatomical Plating System

- Pathway: 510(k) (Special)
- Applicant: Tyber Medical, LLC
- Decided: May 31, 2024 after 30 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: 19 generations back to K962616 (1996). 415 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 418 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153575: Tyber Medical Trauma Screw, Tyber Medical, LLC (2016) Summary page 4.
- K232652: Anatomical Plating System (various), Tyber Medical, LLC (2023) Summary page 4.

## 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
Intended Use: The intended use of the Tyber Medical Anatomical Plating System is to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Frag System and Ankle Fracture/Fusion System with the following indications: 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, but not limited to, 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. Ankle Fracture/Fusion System Tyber Medical Ankle Fracture/Fusion System is indicated for Use in: . Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, periarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; . In intra- and extra articular fractures, osteotomies, medial malleolar fractures and nonunions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus; . In distal tibia/fibula long bones which include the metaphyseal and diaphyseal regions of the tibia and fibula in the ankle. The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use.

Source page: https://510kreport.com/device/K241218
Methodology: https://510kreport.com/methodology