Cleared Special

K041722 - MODIFICATION TO VBR SPINAL SYSTEM

K041722 is the FDA 510(k) clearance for MODIFICATION TO VBR SPINAL SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 91-day FDA review.

K041722 · Depuy Spine, Inc. · Orthopedic device
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Sep 2004
Decision
91d
Days
Class 2
Risk

K041722 is an FDA 510(k) clearance for the MODIFICATION TO VBR SPINAL SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on September 23, 2004 after a review of 91 days - within the typical 510(k) review window.

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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K041722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2004
Decision Date September 23, 2004
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 141
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K041722.
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · Medtronic Sofamor Danek · Jan 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561 · Medtronic Sofamor Danek · Dec 2004
EBI CAS SPINE SPACER SYSTEM
K042268 · Ebi, L.P. · Oct 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
K041939 · Blackstone Medical, Inc. · Aug 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041197 · Medtronic Sofamor Danek · Aug 2004
STRYKER SPINE VERTEBRAL SPACER
K040731 · Stryker Spine · Aug 2004