GRIDLOCK PLATING SYSTEM— 510(k) K121452

Clearance details

Applicant

Trilliant Surgical, Ltd.

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2012-05-16

Decision date

2012-08-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Round Rock, TX, US

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• K130964 — GRIDLOCK PLATING SYSTEM2013-05-08

Death

27

Injury

10,340

Malfunction

3,328

Total

13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1609-2020 — Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.Class II·Terminated·Trilliant Surgical, LLC·20180719
• Z-2490-2015 — 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.Class II·Terminated·Trilliant Surgical Ltd.·20150806
• Z-2738-2015 — 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.Class II·Terminated·Trilliant Surgical Ltd.·20150731
• Z-2456-2015 — Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.Class II·Terminated·Trilliant Surgical Ltd.·20150720

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121452.