Cleared Special

K241396 - uCerv Flux™-C 3D Porous Titanium Cervical Interbody (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241396 · Ulrich Medical USA, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2024
Decision
7d
Days
Class 2
Risk

K241396 is an FDA 510(k) clearance for the uCerv Flux™-C 3D Porous Titanium Cervical Interbody. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Ulrich Medical USA, Inc. (Plano, US). The FDA issued a Cleared decision on May 23, 2024 after a review of 7 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ulrich Medical USA, Inc. devices

Submission Details

510(k) Number K241396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2024
Decision Date May 23, 2024
Days to Decision 7 days
Submission Type Special
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
115d faster than avg
Panel avg: 122d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

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 K241396.
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
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MOD-C
K242303 · Orthomod, LLC · Apr 2026
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K252432 · Spinepoint, LLC · Mar 2026
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