Cleared Special

K262489 - BluEX Cervical Expandable Cage System

K262489 is an FDA 510(k) clearance for BluEX Cervical Expandable Cage System, manufactured by L & K Biomed Co., Ltd.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 29-day FDA review.

K262489 · L & K Biomed Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
29d
Days
Class 2
Risk

K262489 is an FDA 510(k) clearance for the BluEX Cervical Expandable Cage System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on August 18, 2026 after a review of 29 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 L & K Biomed Co., Ltd. devices

FDA 510(k) Submission Details - K262489

510(k) Number K262489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2026
Decision Date August 18, 2026
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

ODP Device Classification - Class 2, Special Controls

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 312
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K262489.
VariLift-C Cervical Interbody Fusion System
K262595 · Wenzel Spine, Inc. · Aug 2026
3d Cage Cervical
K253041 · Fims Co., Ltd. · Jul 2026
Tritanium® C Anterior Cervical Cage
K262061 · Stryker Spine · Jul 2026
C.A. Medical Interbody Fusion System
K254130 · C.A. Medical, LLC · Jul 2026
BluEX Cervical Expandable Cage System
K260840 · L & K Biomed Co., Ltd. · May 2026
OSTEOMNI SPINAL CAGES SYSTEM
K260850 · OSTEOMNI, Inc. · May 2026