Cleared Traditional

K120840 - LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM

K120840 is an FDA 510(k) clearance for LEXUS CERVICAL INTERVERTEBRAL BODY FUSI..., manufactured by L & K Biomed Co., Ltd.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K120840 · L & K Biomed Co., Ltd. · Orthopedic device
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May 2012
Decision
65d
Days
Class 2
Risk

K120840 is an FDA 510(k) clearance for the LEXUS CERVICAL INTERVERTEBRAL BODY FUSION 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. (Geumcheon-Gu, Seoul, KR). The FDA issued a Cleared decision on May 24, 2012 after a review of 65 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all L & K Biomed Co., Ltd. devices

FDA 510(k) Submission Details - K120840

510(k) Number K120840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2012
Decision Date May 24, 2012
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 339
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K120840.
MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
K121569 · Accel Spine · Jul 2012
HONOUR SPACER SYSTEM
K120345 · Nexxt Spine, LLC · Jun 2012
SYNTHES ACIS/VERTEBRAL SPACER CR
K120275 · Synthes (Usa), LLC · May 2012
RELIANCE CERVICAL IBF SYSTEM
K120396 · Reliance Medical Systems, LLC · May 2012
AYERS ROCK CERVICAL CAGE
K112801 · Qualgenix · May 2012
DEPUY PULSE CERVICAL CAGE SYSTEM
K120517 · Medos International SARL · Apr 2012