Cleared Traditional

BIOSPINE VBR SYSTEM (K110864) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 34
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K110864.
T2 STRATOSPHERE™ Expandable Corpectomy System
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FORTIFY Corpectomy Spacers
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NuVasive(r) Monolith Corpectomy System
K170271 · Nu Vasive, Incorporated · Mar 2017
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · Howmedica Osteonics Corp. · Jan 2004
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364 · Synthes (Usa) · Mar 2003