# K233017: TM Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Dec 20, 2023 after 89 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 K954385 (1996). 419 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 421 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System, Stryker GmbH (2023) Summary page 4.
- K210837: Smith & Nephew Plates and Screws, Smith & Nephew, Inc. (2021) Summary page 4.
- K222465: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2023) Summary page 4.

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

## Indications for use
The TM Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the following indication categories: I. TM Plating System – Complete Articular The TM Plating system is indicated for the treatment of nonunions, malunions, osteotomies, and fractures of the femur and tibia. This includes simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures, periprosthetic, and fractures with associated shaft fractures. II. TM Plating System – Partial Articular The partial articular (also called buttress or anti-glide) proximal tibia plates are indicated for stabilization and reduction of proximal tibia fragments and treatment of partial articular fractures of the proximal tibia (AO/OTA Fracture Classifications Type B). The partial articular straight plates are indicated for stabilization and reduction of long bone fragments and partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula.

Source page: https://510kreport.com/device/K233017
Methodology: https://510kreport.com/methodology