# K203817: Tyber Medical Anatomical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Aug 13, 2021 after 227 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: 15 generations back to K954385 (1996). 238 ancestors in all.
10 later devices descend from it; 4 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)
- K193222: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2020) Summary page 5.
- K163039: ORTHOLOC® 3Di Small Bones Plating, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System, Wrightmedicaltechnologyinc (2015) Summary page 5.
- K162439: AxSOS 3 Ti; Stryker Plating System, Stryker GmbH (2017) Summary page 5.
- K190365: Baby Gorilla/Gorilla Plating System, Paragon 28, Inc. (2019) Summary page 5.

## Most influential descendants
- 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
- K242486: Tyber Medical Anatomical Plating System (2025), 1 descendant 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 togethet to facilitate healing and is composed of the following bone plate categories: Mini-frag/Small Bone System The Tyber Medical Mini-Frag/Small Bone System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments including, but are not limited to, the hand, wrist, foot and ankle. The Tyber Medical Mini-frag/Small Bone System is not for Spinal Use. Foot System The Tyber Medical Foot System is Indicated for Use in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals), and 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 small, medium and large bones, revision surgeries and replantations in an adult patient. The Tyber Medical Foot System is not for Spinal Use. Long Bone Fracture System 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. Ankle Fracture/Fusion System 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 Plating System is not for Spinal Use.

Source page: https://510kreport.com/device/K203817
Methodology: https://510kreport.com/methodology