Cleared Traditional

K120345 - HONOUR SPACER SYSTEM

K120345 is an FDA 510(k) clearance for HONOUR SPACER SYSTEM, manufactured by Nexxt Spine, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K120345 · Nexxt Spine, LLC · Orthopedic device
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Jun 2012
Decision
131d
Days
Class 2
Risk

K120345 is an FDA 510(k) clearance for the HONOUR SPACER SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Nexxt Spine, LLC (Chesterland, US). The FDA issued a Cleared decision on June 13, 2012 after a review of 131 days - within the typical 510(k) review window.

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 Nexxt Spine, LLC devices

FDA 510(k) Submission Details - K120345

510(k) Number K120345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2012
Decision Date June 13, 2012
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
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 243
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K120345.
VUSION CS PLUS
K122588 · Ortho Development Corp. · Jun 2013
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
K122366 · Spineart · Oct 2012
AVS AS PEEK SPACER
K120486 · Stryker Spine · Aug 2012
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120840 · L & K Biomed Co., Ltd. · May 2012
RELIANCE CERVICAL IBF SYSTEM
K120396 · Reliance Medical Systems, LLC · May 2012
DEPUY PULSE CERVICAL CAGE SYSTEM
K120517 · Medos International SARL · Apr 2012