Cleared Special

K061576 - MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM

K061576 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 26-day FDA review.

K061576 · Quantum Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
26d
Days
Class 2
Risk

K061576 is an FDA 510(k) clearance for the MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM. 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 July 3, 2006 after a review of 26 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 - K061576

510(k) Number K061576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2006
Decision Date July 03, 2006
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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 K061576.
VERTE-STACK SPINAL SYSTEM
K061938 · Medtronic Sofamor Danek, Inc. · Aug 2006
AVS ASL PEEK SPACER SYSTEM
K061836 · Stryker Spine · Aug 2006
PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
K061151 · Pioneer Surgical Technology · Jul 2006
ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.
K060916 · Spinal Edge, LLC · Jun 2006
EBI ESL PEEK-OPTIMA SPINE SYSTEM
K061016 · Ebi, L.P. · Jun 2006
RETAIN RADIOLUCENT SPACER
K061380 · Globus Medical, Inc. · Jun 2006
K061576 · MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
Download PDF FDA Summary Quantum Orthopedics, …