Cleared Special

K050553 - NOVEL VBR SPINAL SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

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 276
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K050553.
VyBrate™ VBR System
K253158 · Vy Spine, LLC · Jan 2026
Vertiwedge® Intraosseous System
K241468 · Foundation Surgical Group, Inc. · Nov 2024
KONG®-TL VBR System and KONG® C VBR System
K232790 · Icotec AG · Apr 2024
DOMINION Expandable Corpectomy System
K233359 · Astura Medical · Mar 2024
VerteLoc Spinal System
K231134 · Signature Orthopaedics Pty, Ltd. · Feb 2024
Ascend VBR System, Ascend NanoTec VBR System
K232173 · Alphatec Spine, Inc. · Oct 2023