Cleared Special

K052641 - MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT

K052641 is an FDA 510(k) clearance for MODIFICATION TO: QUANTUM VERTEBRAL BODY..., manufactured by Quantum Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 198-day FDA review.

K052641 · Quantum Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
198d
Days
Class 2
Risk

K052641 is an FDA 510(k) clearance for the MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Quantum Orthopedics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 12, 2006 after a review of 198 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Quantum Orthopedics, Inc. devices

FDA 510(k) Submission Details - K052641

510(k) Number K052641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2005
Decision Date April 12, 2006
Days to Decision 198 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 slower than avg
Panel avg: 122d · This submission: 198d
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 217
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K052641.
XPAND RADIOLUCENT CORPECTOMY SPACER
K060665 · Globus Medical, Inc. · May 2006
STAXX XD SYSTEM
K052670 · Spine Wave, Inc. · Apr 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K060719 · Medtronic Sofamor Danek · Apr 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
K060350 · Blackstone Medical, Inc. · Feb 2006
ARX SPINAL SYSTEM
K051525 · Amedica Corp. · Feb 2006
SYNFIX-LR
K053508 · Synthes Spine Co.Lp · Feb 2006