Cleared Traditional

K062254 - AXIS FIXATION SYSTEM

K062254 is the FDA 510(k) clearance for AXIS FIXATION SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 682-day FDA review.

K062254 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Jun 2008
Decision
682d
Days
Class 2
Risk

K062254 is an FDA 510(k) clearance for the AXIS FIXATION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on June 16, 2008 after a review of 682 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Medtronic Sofamor Danek, Inc. devices

Submission Details

510(k) Number K062254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2006
Decision Date June 16, 2008
Days to Decision 682 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
560d slower than avg
Panel avg: 122d · This submission: 682d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K062254.
BLACKSTONE PEDICLE SCREW SYSTEM
K081684 · Blackstone Medical, Inc. · Sep 2008
EXPEDIUM SPINE SYSTEM
K081898 · Depuy Spine, Inc. · Sep 2008
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
K082195 · Depuy Spine, Inc. · Sep 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K081252 · Depuy Spine, Inc. · May 2008
REVERE UNIPLANAR SCREWS
K081195 · Globus Medical, Inc. · May 2008
MODIFICATION TO VIPER SPINE SYSTEM
K073562 · Depuy Spine, Inc. · May 2008