# K061400: Calcaneal Trauma System

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Jun 29, 2006 after 41 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.
53 later devices descend from it; 1 cites it directly.
0 of 54 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 its predicate without a number.
- (no number) DePuy Ace Calcaneal Peri-articular Plate: named in the summary without a submission number

## Most influential descendants
- K113048: Maxlock Extreme System (2012), 52 descendants of its own
- K122005: Maxlock Extreme System (2012), 39 descendants of its own
- K123203: Maxlock Extreme System Model MXL (2012), 38 descendants of its own
- K132591: Maxlock Extreme System (2013), 32 descendants of its own
- K153379: AxSOS 3Ti (2016), 25 descendants of its own

## Indications for use
The Calcaneal Trauma System is indicated for the repair of intra and extra articular fractures of the calcaneus

Source page: https://510kreport.com/device/K061400
Methodology: https://510kreport.com/methodology