Cleared Traditional

K143163 - AVS AL and ALign PEEK Spacers

K143163 is the FDA 510(k) clearance for AVS AL and ALign PEEK Spacers by Stryker Corporation. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K143163 · Stryker Corporation · Orthopedic device
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Jan 2015
Decision
84d
Days
Class 2
Risk

K143163 is an FDA 510(k) clearance for the AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK.... Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on January 26, 2015 after a review of 84 days - a notably fast clearance 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: 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 Stryker Corporation devices

Submission Details

510(k) Number K143163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2014
Decision Date January 26, 2015
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 148
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K143163.
ALIF Interfixated System
K151214 · Nu Vasive, Incorporated · Jun 2015
Chesapeake Stabilization System
K142487 · K2m, Inc. · May 2015
MAGNIFY and MAGNIFY-S Spacers
K142498 · Globus Medical, Inc. · Feb 2015
AERO-LL LUMBAR CAGE SYSTEM
K142066 · Stryker Corporation · Nov 2014
IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
K133947 · X-Spine Systems, Inc. · Jul 2014
COROENT XL-F SYSTEM
K140479 · Nu Vasive, Incorporated · Jul 2014