# K222465: Tyber Medical Anatomical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Mar 7, 2023 after 204 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: 16 generations back to K954385 (1996). 239 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 249 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.
- K193222: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2020)

## Most influential descendants
- K232652: Anatomical Plating System (various) (2023), 3 descendants of its own
- K241218: Tyber Medical Anatomical Plating System (2024), 2 descendants of its own
- K233423: Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System (2023), 2 descendants of its own
- K242486: Tyber Medical Anatomical Plating System (2025), 1 descendant of its own
- K233017: TM Plating System (2023), 1 descendant of its own

## Indications for use
The Tyber Medical Mini-frag System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of short bones and short bone fragments including, but are not limited to, the hand, wrist, foot and ankle. The Tyber Medical Mini-frag System is not for Spinal Use. The Tyber Medical Foot System is Indicated for Use in fixation of short bones and short bone fragments in the foot (Phalanges and Metatarsals), and long bones and long bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of short and long bones, revision surgeries and replantations in an adult patient. The Tyber Medical Foot System is not for Spinal Use. The Tyber Medical Long Bone Fracture System is intended for osteotomies and non-unions, fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, fibula. The Tyber Medical Long Bone Fracture System is not for Spinal Use. The Tyber Medical Ankle Fracture/Fusion System is Indicated for Use in: 1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, perarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; 2). 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; 3). 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 System is not for Spinal Use.

Source page: https://510kreport.com/device/K222465
Methodology: https://510kreport.com/methodology