Cleared Traditional

K111294 - SANTORINI SPINAL SYSTEM

K111294 is an FDA 510(k) clearance for SANTORINI SPINAL SYSTEM, manufactured by K2m, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K111294 · K2m, Inc. · Orthopedic device
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Jan 2012
Decision
262d
Days
Class 2
Risk

K111294 is an FDA 510(k) clearance for the SANTORINI SPINAL SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on January 27, 2012 after a review of 262 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, Inc. devices

FDA 510(k) Submission Details - K111294

510(k) Number K111294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2011
Decision Date January 27, 2012
Days to Decision 262 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
140d slower than avg
Panel avg: 122d · This submission: 262d
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 267
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K111294.
STGC
K121176 · Cardinal Spine, LLC · Aug 2012
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
K121107 · Globus Medical, Inc. · Jul 2012
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
K120570 · Choicespine, LP · Apr 2012
GIZA(R) VERTEBRAL BODY REPLACEMENT
K112429 · Eden Spine, LLC · Jan 2012
STAXX(R) XD SYSTEM
K111418 · Spine Wave, Inc. · Dec 2011
SYNTHES XRL
K103320 · Synthes Spine Co.Lp · Oct 2011