Cleared Traditional

K151726 - AVS AL and AVS ALign PEEK Spacers

K151726 is the FDA 510(k) clearance for AVS AL and AVS ALign PEEK Spacers by Stryker Corporation. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K151726 · Stryker Corporation · Orthopedic device
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Jan 2016
Decision
208d
Days
Class 2
Risk

K151726 is an FDA 510(k) clearance for the AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS T.... 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 Corporation (Allendale, US). The FDA issued a Cleared decision on January 20, 2016 after a review of 208 days - an extended review cycle.

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 Corporation devices

Submission Details

510(k) Number K151726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2015
Decision Date January 20, 2016
Days to Decision 208 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
86d slower than avg
Panel avg: 122d · This submission: 208d
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 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K151726.
ProLift Expandable System
K153400 · Life Spine, Inc. · Mar 2016
PERIMETER Interbody Fusion Device
K160418 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
Rampart A Lumbar Interbody Fusion Device
K153082 · Spineology, Inc. · Feb 2016
Spine Wave Gen II Expandable Interbody System
K152620 · Spine Wave, Inc. · Jan 2016
FORZA PTC Spacer System
K152475 · Orthofix, Inc. · Jan 2016
AccuLIF TL and PL Cage
K152651 · Stryker Corporation · Dec 2015