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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 278
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K050553.
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000 · Spinal Concepts, Inc. · May 2005
THEKEN REVEAL VBR SYSTEM
K050058 · Theken Surgical,Llc · May 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624 · Stryker Spine · Apr 2005
STANSION MATRIX
K042600 · Spineworks, LLC · Feb 2005
STRYKER SPINE AVS TL PEEK SPACER
K042571 · Stryker Spine · Feb 2005
K050553 · NOVEL VBR SPINAL SYSTEM
Download PDF FDA Summary Alphatec/Nexmed