Cleared Traditional

K201585 - Monterey AL Interbody System

K201585 is the FDA 510(k) clearance for Monterey AL Interbody System by Stryker Corporation. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K201585 · Stryker Corporation · Orthopedic device
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Aug 2020
Decision
60d
Days
Class 2
Risk

K201585 is an FDA 510(k) clearance for the Monterey AL Interbody System. 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 August 10, 2020 after a review of 60 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 K201585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2020
Decision Date August 10, 2020
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 147
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K201585.
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K203207 · Omnia Medical, LLC · Dec 2020
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CORBEL Spacers
K201087 · Globus Medical, Inc. · Jul 2020
Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device
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Axis Spine Technologies ALIF
K200352 · Axis Spine Technologies, Ltd. · May 2020