# K090877: Proximal Tibia Locking Plate Standard and Large, 3.5MM Low Profile and Multidirectional Screws

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jun 26, 2009 after 87 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K111663: Trauma Internal Fixation Systems (2012), 1 descendant of its own
- K261207: Exalta Proximal Tibia Plating System (2026), 0 descendants of its own
- K243761: A.L.P.S. Small Fragment Plating System (2025), 0 descendants of its own
- K201917: Piccolo Composite Proximal Tibia Plate System (2020), 0 descendants of its own

## Indications for use
The DePuy Proximal Tibia Plating System is intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.

Source page: https://510kreport.com/device/K090877
Methodology: https://510kreport.com/methodology