# K242486: Tyber Medical Anatomical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Mar 19, 2025 after 210 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: 20 generations back to K962616 (1996). 417 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 419 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232652: Anatomical Plating System (various), Tyber Medical, LLC (2023) Summary page 6.
- K241218: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2024) Summary page 6.
- K233423: Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System, Tyber Medical, LLC (2023) Summary page 6.
- K222465: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2023) Summary page 6.

## Most influential descendants
- K261207: Exalta Proximal Tibia Plating System (2026), 0 descendants of its own

## Indications for use
Intended Use: The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. Indications for Use: Mini-Frag System The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, non-unions, malunions, replantations, and fusion 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 The Tyber Medical Ankle Fracture/Fusion System is indicated for use in: * Fixation of fractures of the distal tibia including, 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 non-unions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus; * In distal tibia/fibula long bones which include the metaphyseal and diaphyseal region of the tibia and fibula in the ankle. The Tyber Medical Ankle Fracture/Fusion System is not for spinal use.

Source page: https://510kreport.com/device/K242486
Methodology: https://510kreport.com/methodology