Cleared Traditional

K253041 - 3d Cage Cervical

K253041 is the FDA 510(k) clearance for 3d Cage Cervical by Fims Co., Ltd.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K253041 · Fims Co., Ltd. · Orthopedic device
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Jul 2026
Decision
304d
Days
Class 2
Risk

K253041 is an FDA 510(k) clearance for the 3d Cage Cervical. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Fims Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on July 23, 2026 after a review of 304 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Fims Co., Ltd. devices

Submission Details

510(k) Number K253041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2025
Decision Date July 23, 2026
Days to Decision 304 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 122d · This submission: 304d
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 216
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K253041.
Tritanium® C Anterior Cervical Cage
K262061 · Stryker Spine · Jul 2026
BluEX Cervical Expandable Cage System
K260840 · L & K Biomed Co., Ltd. · May 2026
OSTEOMNI SPINAL CAGES SYSTEM
K260850 · OSTEOMNI, Inc. · May 2026
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
K260549 · Zsfab, Inc. · Apr 2026
ORIO-3D Cage System
K253260 · SpineCraft · 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