# K193222: Tyber Medical Anatomical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Jan 20, 2020 after 59 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: 13 generations back to K962616 (1996). 207 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162674: BioPro Foot Plating Systems, Biopro, Inc. (2017) Summary page 5.

## Most influential descendants
- K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own
- K222465: Tyber Medical Anatomical Plating System (2023), 9 descendants of its own
- 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

## Indications for use
The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following bone plate categories: I. Forefoot System: The Tyber Medical Forefoot Plating System is Indicated for Use in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Tyber Medical Forefoot System is not for Spinal Use. II. Mid & Hindfoot System: The Tyber Medical Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient. The Tyber Medical Mid & Hindfoot System is not for Spinal Use. III. Ankle Fracture System: The Tyber Medical Ankle Fracture 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; 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 System is not for Spinal Use.

Source page: https://510kreport.com/device/K193222
Methodology: https://510kreport.com/methodology