Cleared Traditional

K051105 - BASIS VERTEBRAL BODY SPACER

K051105 is the FDA 510(k) clearance for BASIS VERTEBRAL BODY SPACER by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K051105 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
38d
Days
Class 2
Risk

K051105 is an FDA 510(k) clearance for the BASIS VERTEBRAL BODY SPACER. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on June 9, 2005 after a review of 38 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K051105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2005
Decision Date June 09, 2005
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K051105.
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · Implex Corp. · Sep 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
K051196 · Implex Corp. · Jun 2005
CONSTRUX MINI PEEK VBR SYSTEM
K051246 · Blackstone Medical, Inc. · Jun 2005
PEEK CAS
K050861 · Interpore Cross Intl. · May 2005
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000 · Spinal Concepts, Inc. · May 2005