Cleared Traditional

K073267 - ENDIUS MINIT POSTERIOR CERVICAL AND UPP...

K073267 is the FDA 510(k) clearance for ENDIUS MINIT POSTERIOR CERVICAL AND UPP... by Endius, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K073267 · Endius, Inc. · Orthopedic device
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Jan 2008
Decision
71d
Days
Class 2
Risk

K073267 is an FDA 510(k) clearance for the ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC 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 Endius, Inc. (Plainville, US). The FDA issued a Cleared decision on January 30, 2008 after a review of 71 days - a notably fast clearance cycle.

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: 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 Endius, Inc. devices

Submission Details

510(k) Number K073267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2007
Decision Date January 30, 2008
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 K073267.
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K080518 · Pioneer Surgical Technology · Mar 2008
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K080258 · Endius, Inc. · Mar 2008
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
K073510 · Endius, Inc. · Feb 2008
LIFE SPINE CROSS CONNECTOR
K073480 · Life Spine · Jan 2008
H-LINK INTEGRATED ROD
K073517 · Globus Medical, Inc. · Jan 2008
BEACON STABILIZATION SYSTEM
K073172 · Globus Medical, Inc. · Dec 2007