Cleared Traditional

K221138 - Titus Titanium Cervical by SAGICO (FDA 510(k) Clearance)

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

K221138 · Sagico VA USA, LLC · Orthopedic device
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Aug 2023
Decision
472d
Days
Class 2
Risk

K221138 is an FDA 510(k) clearance for the Titus Titanium Cervical by SAGICO. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Sagico VA USA, LLC (Tampa, US). The FDA issued a Cleared decision on August 4, 2023 after a review of 472 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Sagico VA USA, LLC devices

Submission Details

510(k) Number K221138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2022
Decision Date August 04, 2023
Days to Decision 472 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
350d slower than avg
Panel avg: 122d · This submission: 472d
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 159
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K221138.
SABER-C System
K260660 · Elevation Spine · Apr 2026
SAGI Cervical Cage System
K253213 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
Uni-C Cervical Cage System
K252774 · ZheJiang Decans Medical Devices Co., Ltd. · Apr 2026
E3D™-C Interbody System
K260038 · Evolution Spine · Feb 2026
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
K253876 · Globus Medical, Inc. · Dec 2025
Cervical Spine Truss System - Stand Alone (CSTS-SA)
K253200 · 4Web Medical, Inc. · Dec 2025