Cleared Traditional

K110864 - BIOSPINE VBR SYSTEM

K110864 is an FDA 510(k) clearance for BIOSPINE VBR SYSTEM, manufactured by Aesculap Implant Systems, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K110864 · Aesculap Implant Systems, LLC · Orthopedic device
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Jun 2011
Decision
78d
Days
Class 2
Risk

K110864 is an FDA 510(k) clearance for the BIOSPINE VBR SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on June 15, 2011 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aesculap Implant Systems, LLC devices

FDA 510(k) Submission Details - K110864

510(k) Number K110864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2011
Decision Date June 15, 2011
Days to Decision 78 days
Submission Type Traditional
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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 191
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K110864.
FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS
K112756 · Globus Medical, Inc. · Oct 2011
STAXX XDL SYSTEM
K102315 · Spine Wave, Inc. · Aug 2011
STAXXSD SYSTEM
K111469 · Spine Wave, Inc. · Jul 2011
STAXX(R) XD SYSTEM
K102682 · Spine Wave, Inc. · Nov 2010
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · Medtronic Sofamor Danek USA, Inc. · Oct 2010
STAXX XD SYSTEM
K101288 · Spine Wave, Inc. · Sep 2010