Cleared Traditional

K173115 - COALITION and COALITION TPS

K173115 is the FDA 510(k) clearance for COALITION and COALITION TPS by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K173115 · Globus Medical, Inc. · Orthopedic device
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Dec 2017
Decision
82d
Days
Class 2
Risk

K173115 is an FDA 510(k) clearance for the COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITI.... Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 20, 2017 after a review of 82 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K173115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date December 20, 2017
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K173115.
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
NuVasive® Modulus-C Interbody System
K172676 · Nu Vasive, Incorporated · Dec 2017
Vertera Spine Cohere Cervical Interbody Fusion Device
K173030 · Nu Vasive, Incorporated · Nov 2017
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
K172437 · Orthofix, Inc. · Nov 2017