Cleared Traditional

K083661 - AVS TL PEEK SPACERS

K083661 is the FDA 510(k) clearance for AVS TL PEEK SPACERS by Stryker Corp.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K083661 · Stryker Corp. · Orthopedic device
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Feb 2009
Decision
79d
Days
Class 2
Risk

K083661 is an FDA 510(k) clearance for the AVS TL PEEK SPACERS. 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 Corp. (Allendale, US). The FDA issued a Cleared decision on February 27, 2009 after a review of 79 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 Corp. devices

Submission Details

510(k) Number K083661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2008
Decision Date February 27, 2009
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
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 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K083661.
AVS ANTERIOR LARGE PEEK SPACERS
K090166 · Stryker Corp. · Apr 2009
NOVEL ALIF SPINAL SPACER SYSTEM
K090782 · Alphatec Spine, Inc. · Apr 2009
ALEUTIAN IBF SYSTEM
K082698 · K2m, Inc. · Apr 2009
DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE
K081888 · Spineart · Feb 2009
EXPANDABLE PEEK-OPTIMA IMPLANT
K082406 · Ebi, L.P. · Jan 2009
CLYDESDALE SPINAL SYSTEM
K083026 · Medtronic Sofamor Danek · Dec 2008