Cleared Traditional

K253260 - ORIO-3D Cage System (FDA 510(k) Clearance)

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

K253260 · SpineCraft · Orthopedic device
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Apr 2026
Decision
199d
Days
Class 2
Risk

K253260 is an FDA 510(k) clearance for the ORIO-3D Cage System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by SpineCraft (Westmont, US). The FDA issued a Cleared decision on April 16, 2026 after a review of 199 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.

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Submission Details

510(k) Number K253260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date April 16, 2026
Days to Decision 199 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
77d slower than avg
Panel avg: 122d · This submission: 199d
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 345
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K253260.
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
K260549 · Zsfab, Inc. · Apr 2026
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
K260340 · HC Biologics, LLC · Apr 2026
MOD-C
K242303 · Orthomod, LLC · Apr 2026
Flex-Z™ Cervical Cage
K252432 · Spinepoint, LLC · Mar 2026
Hive™ Standalone Cervical System and Hive™ C Interbody System
K254105 · NanoHive Medical, LLC · Feb 2026
Curiteva Porous PEEK Cervical Interbody System
K252205 · Curiteva, Inc. · Jan 2026