Cleared Traditional

K121452 - GRIDLOCK PLATING SYSTEM

K121452 is an FDA 510(k) clearance for GRIDLOCK 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 96-day FDA review.

K121452 · Trilliant Surgical, Ltd. · Orthopedic device
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Aug 2012
Decision
96d
Days
Class 2
Risk

K121452 is an FDA 510(k) clearance for the GRIDLOCK 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. (Round Rock, US). The FDA issued a Cleared decision on August 20, 2012 after a review of 96 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Trilliant Surgical, Ltd. devices

FDA 510(k) Submission Details - K121452

510(k) Number K121452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2012
Decision Date August 20, 2012
Days to Decision 96 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 122d · This submission: 96d
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 Peers - HRS Plate, Fixation, Bone

All 1034
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K121452.
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF
K113648 · Aap Implantate AG · Sep 2012
MAXLOCK EXTREME SYSTEM
K122005 · Orthohelix Surgical Designs, Inc. · Sep 2012
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T
K113652 · Aap Implantate AG · Aug 2012
PIONEER STERNAL ASSIST IMPLANT SYSTEM
K120016 · Pioneer Surgical Technology, Inc. · Jul 2012
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
K120903 · Acumed, LLC · Jul 2012
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE
K121601 · Synthes (Usa) · Jul 2012