# K121452: Gridlock Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Aug 20, 2012 after 96 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K091614 (2009). 1 ancestor in all.
11 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091614: Osteomed Foot Plating System, Osteomed LP (2009) Summary page 1.

## Most influential descendants
- K172178: Minimally Invasive Bunion Plating System (2017), 4 descendants of its own
- K123525: Gridlock Plating System (2013), 4 descendants of its own
- K211650: The Radian MIS Bunion System (2021), 3 descendants of its own
- K160177: Gridlock Ankle Plating System (2016), 3 descendants of its own
- K130964: Gridlock Plating System (2013), 3 descendants of its own

## Recalls of this device
- Jul 19, 2018 · Class II · Z-1609-2020: Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
- Aug 6, 2015 · Class II · Z-2490-2015: The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficien
- Jul 31, 2015 · Class II · Z-2738-2015: Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an in
- Jul 20, 2015 · Class II · Z-2456-2015: The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.

## Indications for use
The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The plates and screws are intended for single use only.

Source page: https://510kreport.com/device/K121452
Methodology: https://510kreport.com/methodology