Cleared Special

K173102 - Reliance Cervical IBF System

K173102 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 Special 510(k) pathway after a 91-day FDA review.

K173102 · Reliance Medical Systems, LLC · Orthopedic device
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Dec 2017
Decision
91d
Days
Class 2
Risk

K173102 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 December 29, 2017 after a review of 91 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Reliance Medical Systems, LLC devices

Submission Details

510(k) Number K173102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date December 29, 2017
Days to Decision 91 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

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 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K173102.
Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device
K173535 · Titan Spine, LLC · Feb 2018
MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
K172212 · Ctl Medical Corporation · Jan 2018
Cervical Spinal Truss System (CSTS) Interbody Fusion Device
K173159 · 4Web, Inc. · Jan 2018
SeaSpine Vu cPOD, Zuma-C, Complete Cervical
K172926 · SeaSpine Orthopedics Corporation · Dec 2017
COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
K173115 · Globus Medical, Inc. · Dec 2017
NuVasive® Modulus-C Interbody System
K172676 · Nu Vasive, Incorporated · Dec 2017