# K090582: Calcaneal Fracture Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Jul 2, 2009 after 120 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: 3 generations back to K915818 (1992). 7 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 2.
- K041786: Calcamea Plate, New Deal, S.A. (2004) Summary page 2.

## Most influential descendants
- K132898: A.L.P.S. Calcaneal Plating System (2013), 11 descendants of its own
- K171808: TDM Plate and Screw System (2018), 6 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K221150: Advanced Bone Plate (2023), 1 descendant of its own
- K190391: TDM Plate and Screw Systems (2019), 1 descendant of its own

## Indications for use
The Tornier Calcaneal Fracture Plate System is indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue-type and severely comminuted fractures.

Source page: https://510kreport.com/device/K090582
Methodology: https://510kreport.com/methodology