Cleared Traditional

K082466 - XYCOR SPINAL IMPLANT

K082466 is an FDA 510(k) clearance for XYCOR SPINAL IMPLANT, manufactured by Vertebration,Inc. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K082466 · Vertebration,Inc · Orthopedic device
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Jan 2009
Decision
135d
Days
Class 2
Risk

K082466 is an FDA 510(k) clearance for the XYCOR SPINAL IMPLANT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Vertebration,Inc (Cincinnati, US). The FDA issued a Cleared decision on January 9, 2009 after a review of 135 days - within the typical 510(k) review window.

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 Vertebration,Inc devices

FDA 510(k) Submission Details - K082466

510(k) Number K082466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2008
Decision Date January 09, 2009
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
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 213
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K082466.
STAXX XD SYSTEM
K090315 · Spine Wave, Inc. · Sep 2009
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
K090176 · Nuvasive, Inc. · Apr 2009
LDR SPINE ROI-C IMPLANT
K083857 · Ldr Spine USA · Feb 2009
T2 XVBR SPINAL SYSTEM
K082112 · Medtronic Sofamor Danek · Aug 2008
RELIANCE VBS SYSTEM
K081383 · Reliance Medical Systems, LLC · Jul 2008
ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM
K081332 · Signus Medizintechnik GmbH · Jun 2008