Cleared Special

K050553 - NOVEL VBR SPINAL SYSTEM

K050553 is an FDA 510(k) clearance for NOVEL VBR SPINAL SYSTEM, manufactured by Alphatec/Nexmed. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 46-day FDA review.

K050553 · Alphatec/Nexmed · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
46d
Days
Class 2
Risk

K050553 is an FDA 510(k) clearance for the NOVEL VBR SPINAL SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Alphatec/Nexmed (Carlsbad, US). The FDA issued a Cleared decision on April 18, 2005 after a review of 46 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 Alphatec/Nexmed devices

FDA 510(k) Submission Details - K050553

510(k) Number K050553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2005
Decision Date April 18, 2005
Days to Decision 46 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 122d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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 219
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K050553.
PEEK CAS
K050861 · Interpore Cross Intl. · May 2005
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000 · Spinal Concepts, Inc. · May 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624 · Stryker Spine · Apr 2005
STRYKER SPINE AVS TL PEEK SPACER
K042571 · Stryker Spine · Feb 2005
RABEA SPINAL IMPLANT
K043316 · Signus Medizintechnik GmbH · Feb 2005