Cleared Traditional

DEXA-C Cervical Interbody System (K210521) - FDA 510(k) Clearance

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

K210521 · Aurora Spine, Inc. · Orthopedic device
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Aug 2021
Decision
160d
Days
Class 2
Risk

K210521 is an FDA 510(k) clearance for the DEXA-C Cervical Interbody System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Aurora Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 2, 2021 after a review of 160 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 Aurora Spine, Inc. devices

Submission Details

510(k) Number K210521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2021
Decision Date August 02, 2021
Days to Decision 160 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
38d slower than avg
Panel avg: 122d · This submission: 160d
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 Consultant

Watershed Idea Foundry
Jeffrey Brittan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K210521.
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System
K211704 · Orthofix, Inc. · Aug 2021
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K212038 · K&J Consulting Corporation · Aug 2021
Advantage-C PEEK Cervical lnterbody Fusion Device
K211501 · Lntelivation, LLC · Aug 2021
GPS Cervical Spacers
K210890 · G Surgical, LLC · Apr 2021
Blustone Synergy Interbody Fusion System
K203520 · Blustone Synergy, LLC · Apr 2021
CONSTRUX Mini Ti Spacer System
K203342 · Orthofix, Inc. · Mar 2021