Cleared Traditional

K253213 - SAGI Cervical Cage System (FDA 510(k) Clearance)

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

K253213 · ZheJiang Decans Medical Devices Co., Ltd. · Orthopedic device
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Apr 2026
Decision
203d
Days
Class 2
Risk

K253213 is an FDA 510(k) clearance for the SAGI Cervical Cage System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by ZheJiang Decans Medical Devices Co., Ltd. (Jiaxing, CN). The FDA issued a Cleared decision on April 20, 2026 after a review of 203 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 ZheJiang Decans Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K253213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date April 20, 2026
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 K253213.
SABER-C System
K260660 · Elevation Spine · 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
Endeavor™ Stand-Alone Cervical IBF System
K250076 · Innovasis · Sep 2025