Cleared Traditional

K050484 - BASIS SPINAL SYSTEM

K050484 is the FDA 510(k) clearance for BASIS SPINAL SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K050484 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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May 2005
Decision
68d
Days
Class 2
Risk

K050484 is an FDA 510(k) clearance for the BASIS SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on May 4, 2005 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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, Inc. devices

Submission Details

510(k) Number K050484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2005
Decision Date May 04, 2005
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K050484.
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CD HORIZON SPINAL SYSTEM
K050809 · Medtronic Sofamor Danek USA, Inc. · Jun 2005
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K043053 · Medtronic Sofamor Danek · Apr 2005
TECHTONIX SYSTEM
K050189 · Stryker Spine · Feb 2005
CD HORIZON SPINAL SYSTEM
K050079 · Medtronic Sofamor Danek USA, Inc. · Feb 2005