Cleared Special

K050850 - XPAND CORPECTOMY SPACER

K050850 is the FDA 510(k) clearance for XPAND CORPECTOMY SPACER by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 52-day FDA review.

K050850 · Globus Medical, Inc. · Orthopedic device
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May 2005
Decision
52d
Days
Class 2
Risk

K050850 is an FDA 510(k) clearance for the XPAND CORPECTOMY SPACER. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Phoenixville, US). The FDA issued a Cleared decision on May 26, 2005 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K050850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2005
Decision Date May 26, 2005
Days to Decision 52 days
Submission Type Special
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
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K050850.
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K050624 · Stryker Spine · Apr 2005
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K042571 · Stryker Spine · Feb 2005