# K160177: Gridlock Ankle Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Apr 22, 2016 after 86 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962616 (1996). 104 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143385: Acumed Ankle Plating System, Acumed, LLC (2015) Summary page 4.
- K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K121452: Gridlock Plating System, Trilliant Surgical, Ltd. (2012) Summary page 4.
- K040860: Integra Bone Fixation System, Integra LifeSciences Corporation (2004) Summary page 4.

## Most influential descendants
- K191009: Arsenal Plating System (2019), 2 descendants of its own
- K212378: Arsenal Ankle Plating System (2022), 0 descendants of its own
- K200062: Foot and Ankle System (2021), 0 descendants of its own

## Recalls of this device
- Jul 19, 2018 · Class II · Z-1613-2020: Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.

## Indications for use
The Gridlock Ankle Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device. The plates (implant), screws (implant), washers (implant), olive wires (instrument), and guide wires (instrument) are intended for single use only.

Source page: https://510kreport.com/device/K160177
Methodology: https://510kreport.com/methodology