Cleared Traditional

K173722 - PATRIOT COLONIAL Spacer

K173722 is the FDA 510(k) clearance for PATRIOT COLONIAL Spacer by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K173722 · Globus Medical, Inc. · Orthopedic device
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May 2018
Decision
169d
Days
Class 2
Risk

K173722 is an FDA 510(k) clearance for the PATRIOT COLONIAL Spacer, SUSTAIN Spacer. 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 May 23, 2018 after a review of 169 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K173722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2017
Decision Date May 23, 2018
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
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 K173722.
EVOL® ha-C Cervical Interbody Fusion System
K180674 · Cutting Edge Spine, LLC · Jun 2018
TiWAVE-C™ Porous Titanium Cervical Cage
K180401 · Kalitec Direct, LLC · Jun 2018
Atlas Spine Expandable Cervical Interbody System
K180675 · Atlas Spine, Inc. · Jun 2018
icotec Interbody Cage System
K172480 · Icotec AG · May 2018
InTice™-C Porous Ti Cervical Interbody System
K173832 · X-Spine Systems, Inc. · May 2018
Cervage
K172568 · Precifit Medical, Ltd. · May 2018