Cleared Traditional

DOLOMITE Anterior Cervical Stabilization System (K202065) - FDA 510(k) Clearance

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

K202065 · Astura Medical, LLC · Orthopedic device
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Oct 2020
Decision
91d
Days
Class 2
Risk

K202065 is an FDA 510(k) clearance for the DOLOMITE Anterior Cervical Stabilization System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Astura Medical, LLC (Irving, US). The FDA issued a Cleared decision on October 26, 2020 after a review of 91 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.

View all Astura Medical, LLC devices

Submission Details

510(k) Number K202065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2020
Decision Date October 26, 2020
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 93
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K202065.
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
K203129 · Precision Spine, Inc. · Jan 2021
IdentiTi Cervical Standalone Interbody System
K202812 · Alphatec Spine, Inc. · Dec 2020
Mecta-C Stand Alone Extension
K203076 · Medacta International S.A. · Nov 2020
Hexanium® ACIF
K193000 · Spinevision, S.A.S. · Oct 2020
Cavetto-SA Cervical Cage System
K200115 · Neurostructures, Inc. · Sep 2020
Seaspine WaveForm C Interbody System
K201073 · SeaSpine Orthopedics Corporation · Sep 2020