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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 278
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K052641.
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K060350 · Blackstone Medical, Inc. · Feb 2006
ARX SPINAL SYSTEM
K051525 · Amedica Corp. · Feb 2006
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K053508 · Synthes Spine Co.Lp · Feb 2006
K052641 · MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT
Download PDF FDA Summary Quantum Orthopedics, …