Cleared Traditional

K180665 - SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System

K180665 is an FDA 510(k) clearance for SANTORINI Corpectomy Cage System, manufactured by K2m, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K180665 · K2m, LLC · Orthopedic device
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Nov 2018
Decision
259d
Days
Class 2
Risk

K180665 is an FDA 510(k) clearance for the SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by K2m, LLC (Leesburg, US). The FDA issued a Cleared decision on November 28, 2018 after a review of 259 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 K2m, LLC devices

FDA 510(k) Submission Details - K180665

510(k) Number K180665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2018
Decision Date November 28, 2018
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 236
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K180665.
PYRAMESH™ Implant System
K183197 · Medtronic Sofamor Danek USA, Inc. · Apr 2019
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
K183588 · Choicespine · Feb 2019
T2 STRATOSPHERE Expandable Corpectomy System
K183510 · Medtronic Sofamor Danek USA, Inc. · Jan 2019
Solidity Vertebral Body Replacement
K181921 · Ulrich Medical USA · Nov 2018
FORTIFY Corpectomy Spacers
K173982 · Globus Medical, Inc. · Sep 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K181328 · Medtronic Sofamor Danek USA, Inc. · Sep 2018