Cleared Traditional

AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX (K100865) - FDA 510(k) Clearance

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

K100865 · Stryker Spine · Orthopedic device
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Aug 2010
Decision
135d
Days
Class 2
Risk

K100865 is an FDA 510(k) clearance for the AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX. 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 Stryker Spine (Allendale, US). The FDA issued a Cleared decision on August 11, 2010 after a review of 135 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Spine devices

Submission Details

510(k) Number K100865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2010
Decision Date August 11, 2010
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
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 K100865.
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
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K082732 · Medtronic Sofamor Danek USA, Inc. · Oct 2008
CAPSTONE SPINAL SYSTEM
K073291 · Medtronic Sofamor Danek USA, Inc. · Apr 2008