Cleared Traditional

K120486 - AVS AS PEEK SPACER

K120486 is the FDA 510(k) clearance for AVS AS PEEK SPACER by Stryker Spine. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K120486 · Stryker Spine · Orthopedic device
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Aug 2012
Decision
185d
Days
Class 2
Risk

K120486 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 Spine (Allendale, US). The FDA issued a Cleared decision on August 20, 2012 after a review of 185 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 Spine devices

Submission Details

510(k) Number K120486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2012
Decision Date August 20, 2012
Days to Decision 185 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
63d slower than avg
Panel avg: 122d · This submission: 185d
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 223
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K120486.
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · Medtronic Sofamor Danek USA, Inc. · Sep 2013
VUSION CS PLUS
K122588 · Ortho Development Corp. · Jun 2013
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
K122366 · Spineart · Oct 2012
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120840 · L & K Biomed Co., Ltd. · May 2012
DEPUY PULSE CERVICAL CAGE SYSTEM
K120517 · Medos International SARL · Apr 2012
MECTA-C
K112862 · Medacta International · Dec 2011