Cleared Special

K190598 - CROSSWAY Spinal Access System

K190598 is the FDA 510(k) clearance for CROSSWAY Spinal Access System by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K190598 · Globus Medical, Inc. · Orthopedic device
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Apr 2019
Decision
29d
Days
Class 2
Risk

K190598 is an FDA 510(k) clearance for the CROSSWAY Spinal Access System. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on April 5, 2019 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K190598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2019
Decision Date April 05, 2019
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - HRX Arthroscope

All 376
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K190598.
Nuvis Battery Arthroscope
K191594 · Integrated Endoscopy, Inc. · Jul 2019
HydroCision TenJet Device
K190804 · Hydrocision, Inc. · Jun 2019
MEDINAUT Plus
K182287 · Imedicom Co., Ltd. · Apr 2019
CORUS Spinal System
K190201 · Providence Medical Technology, Inc. · Mar 2019
Pristine Scope
K183165 · Pristine Surgical · Jan 2019
Precision Ideal Eyes Arthroscopes
K183470 · Stryker · Jan 2019