Cleared Traditional

ETURN SPINAL IMPLANT MODEL ETURN XX-12 (K100305) - FDA 510(k) Clearance

Also marketed or referenced as:
ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K ETURN XX-16 K WHER

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

K100305 · Icotec · Orthopedic device
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Jul 2011
Decision
533d
Days
Class 2
Risk

K100305 is an FDA 510(k) clearance for the ETURN SPINAL IMPLANT MODEL ETURN XX-12. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Icotec (Minneapolis, US). The FDA issued a Cleared decision on July 21, 2011 after a review of 533 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Icotec devices

Submission Details

510(k) Number K100305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2010
Decision Date July 21, 2011
Days to Decision 533 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
411d slower than avg
Panel avg: 122d · This submission: 533d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 436
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K100305.
CLYDESDALE(R) SPINAL SYSTEM
K113528 · Medtronic Sofamor Danek USA, Inc. · Dec 2011
CLYDESDALES SPINAL SYSTEM
K112405 · Medtronic Sofamor Danek USA, Inc. · Nov 2011
CRESCENT (R) SPINAL SYSTEM TITANIUM
K110543 · Medtronic Sofamor Danek USA, Inc. · Aug 2011
CALIBER SPACER
K102293 · Globus Medical, Inc. · Jan 2011
PATRIOT TRANSCONTINENTAL M SPACERS
K102313 · Globus Medical, Inc. · Dec 2010
PATRIOT TRANSCONTINENTAL LLIF SPACER
K093242 · Globus Medical, Inc. · Dec 2009