Cleared Traditional

K181898 - Two-Step Implant System

K181898 is an FDA 510(k) clearance for Two-Step Implant System, manufactured by Trilliant Surgical. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K181898 · Trilliant Surgical · Orthopedic device
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Oct 2018
Decision
102d
Days
Class 2
Risk

K181898 is an FDA 510(k) clearance for the Two-Step Implant System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Trilliant Surgical (Houston, US). The FDA issued a Cleared decision on October 26, 2018 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 devices

FDA 510(k) Submission Details - K181898

510(k) Number K181898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2018
Decision Date October 26, 2018
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 690
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K181898.
Responsive Arthroscopy Interference Screw System
K180573 · Responsive Arthroscopy, LLC · Nov 2018
HammerTechTM Fixation System
K182684 · Fusion Orthopedics, LLC · Nov 2018
DePuy Synthes 2.0 mm Quick Insertion Screws
K180541 · Synthes USA Products, LLC · Nov 2018
SILVERBACK Gorilla Plating System
K182148 · Paragon 28, Inc. · Sep 2018
Field Orthopaedics Micro Screw System
K180348 · Field Orthopaedics Pty, Ltd. · Jul 2018
Injection Screw
K173556 · Biedermann Medtech, Inc. · Jul 2018