Cleared Traditional

K160177 - Gridlock Ankle Plating System

K160177 is an FDA 510(k) clearance for Gridlock Ankle Plating System, manufactured by Trilliant Surgical, Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K160177 · Trilliant Surgical, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
86d
Days
Class 2
Risk

K160177 is an FDA 510(k) clearance for the Gridlock Ankle Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Trilliant Surgical, Ltd. (Houston, US). The FDA issued a Cleared decision on April 22, 2016 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K160177

510(k) Number K160177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date April 22, 2016
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

The OrthoMedix Group, Inc.
J.D. Webb

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1312
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K160177.
OsteoMed ExtremiLOCK Wrist Plating System
K161041 · Osteomed · May 2016
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
K153716 · Gpc Medical, Ltd. · May 2016
MotoBand(TM) CP Implant System
K160300 · Crossroads Extremity Systems, LLC · Apr 2016
G3(TM) Active Plate(R) Small Fragment System
K160633 · Genesis Fracture Care, Inc. · Apr 2016
KLS Martin Thoracic Plating System
K153482 · KLS-Martin L.P. · Apr 2016