Cleared Special

K042268 - EBI CAS SPINE SPACER SYSTEM

K042268 is the FDA 510(k) clearance for EBI CAS SPINE SPACER SYSTEM by Ebi, L.P.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 65-day FDA review.

K042268 · Ebi, L.P. · Orthopedic device
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Oct 2004
Decision
65d
Days
Class 2
Risk

K042268 is an FDA 510(k) clearance for the EBI CAS SPINE SPACER SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on October 27, 2004 after a review of 65 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 Ebi, L.P. devices

Submission Details

510(k) Number K042268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2004
Decision Date October 27, 2004
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K042268.
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · Medtronic Sofamor Danek · Jan 2005
TITANIUM MESH IMPLANT
K041407 · Interpore Cross Intl. · Dec 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561 · Medtronic Sofamor Danek · Dec 2004
SYNTHES CONTOURED SYNMESH SPACER
K041389 · Synthes Spine · Oct 2004
MODIFICATION TO VBR SPINAL SYSTEM
K041722 · Depuy Spine, Inc. · Sep 2004
EXPANDABLE PEEK VBR IMPLANT
K040928 · Interpore Cross Intl. · Aug 2004