Cleared Traditional

AVS AS PEEK Spacer (K142251) - FDA 510(k) Clearance

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

K142251 · Stryker Corporation · Orthopedic device
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Nov 2014
Decision
97d
Days
Class 2
Risk

K142251 is an FDA 510(k) clearance for the AVS AS PEEK Spacer. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on November 19, 2014 after a review of 97 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.

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Submission Details

510(k) Number K142251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2014
Decision Date November 19, 2014
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 177
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K142251.
PERIMETER C (Titanium) Spinal System
K153438 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
Ascendant TM Cervical Spacer System
K150130 · Exactech, Inc. · May 2015
Coalition AGX Plate and Coalition AGX Spacer
K142218 · Globus Medical, Inc. · Mar 2015
DIVERGENCE Anterior Cervical Fusion System
K142450 · Medtronic Sofamor Danek USA, Inc. · Oct 2014
EXACTECH CERVICAL SPACER SYSTEM
K141129 · Exactech, Inc. · Aug 2014
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
K133653 · Medtronic Sofamor Danek USA, Inc. · Apr 2014