# K261207: Exalta Proximal Tibia Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Jun 12, 2026 after 60 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: 21 generations back to K962616 (1996). 542 ancestors in all.
No later device cites it as a predicate yet.
0 of 543 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233017: TM Plating System, Tyber Medical, LLC (2023) Summary page 5.
- K090877: Proximal Tibia Locking Plate Standard and Large, 3.5MM Low Profile and Multidirectional Screws, DePuy Orthopaedics, Inc. (2009) Summary page 5.
- K242486: Tyber Medical Anatomical Plating System, Tyber Medical, LLC (2025) Summary page 5.

## Indications for use
The Exalta Proximal Tibia Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the following indication categories: I. Complete Articular – The Exalta Proximal Tibia 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. 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. III. Mini-Frag -- The Exalta Proximal Tibia Plating System is indicated for fixation of fractures, osteotomies, non-unions, replantations, and fusions of short bones and small bone fragments of bone, including, but not limited to, the hand, wrist, foot, and ankle. The Exalta Proximal Tibia Plating System is also intended for reduction and stabilization of non-load bearing long bone fragments. The Exalta Proximal Tibia Plating System is not for spinal use.

Source page: https://510kreport.com/device/K261207
Methodology: https://510kreport.com/methodology