Cleared Special

K122622 - ENDURAMESH

K122622 is an FDA 510(k) clearance for ENDURAMESH, manufactured by Lucero Medical, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 22-day FDA review.

K122622 · Lucero Medical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
22d
Days
Class 2
Risk

K122622 is an FDA 510(k) clearance for the ENDURAMESH. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Lucero Medical, LLC (Avon Lake, US). The FDA issued a Cleared decision on September 19, 2012 after a review of 22 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 - K122622

510(k) Number K122622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2012
Decision Date September 19, 2012
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
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 K122622.
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
K131724 · Pioneer Surgical Technology, Inc. · Dec 2013
STAXX(R) SYSTEM
K133207 · Spine Wave, Inc. · Dec 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888 · Medtronic Sofamor Danek, Inc. · Sep 2013
STAXX XD SYSTEM
K121889 · Spine Wave, Inc. · Aug 2012
STGC
K121176 · Cardinal Spine, LLC · Aug 2012
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
K121107 · Globus Medical, Inc. · Jul 2012
K122622 · ENDURAMESH
Download PDF FDA Summary Lucero Medical, LLC