Cleared Traditional

K142269 - Reliance Cervical IBF System

K142269 is the FDA 510(k) clearance for Reliance Cervical IBF System by Reliance Medical Systems, LLC. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K142269 · Reliance Medical Systems, LLC · Orthopedic device
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Jun 2015
Decision
298d
Days
Class 2
Risk

K142269 is an FDA 510(k) clearance for the Reliance Cervical IBF System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on June 9, 2015 after a review of 298 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 Reliance Medical Systems, LLC devices

Submission Details

510(k) Number K142269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2014
Decision Date June 09, 2015
Days to Decision 298 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
176d slower than avg
Panel avg: 122d · This submission: 298d
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 220
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K142269.
Foundation Interbody Devices
K150847 · Corelink, LLC · Aug 2015
LnK Cervical Interbody Fusion Cage System
K151677 · L & K Biomed Co., Ltd. · Jul 2015
NuVasive CoRoent Small Interbody System
K150362 · Nu Vasive, Incorporated · Jun 2015
Ascendant TM Cervical Spacer System
K150130 · Exactech, Inc. · May 2015
Mecta-C TiPEEK
K142744 · Medacta International · May 2015
LnK Cervical Interbody Fusion Cage System
K143360 · L & K Biomed Co., Ltd. · Apr 2015