Cleared Special

K192526 - Spine Wave Navigated Instruments

K192526 is the FDA 510(k) clearance for Spine Wave Navigated Instruments by Spine Wave, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Special 510(k) pathway after a 27-day FDA review.

K192526 · Spine Wave, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
27d
Days
Class 2
Risk

K192526 is an FDA 510(k) clearance for the Spine Wave Navigated Instruments. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on October 10, 2019 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 Spine Wave, Inc. devices

Submission Details

510(k) Number K192526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2019
Decision Date October 10, 2019
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 365
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K192526.
ROSA ONE Spine application
K192173 · Medtech S.A · Oct 2019
Zimmer Biomet Universal Navigation System
K190556 · Zimmer Biomet Spine, Inc. · Oct 2019
SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
K191943 · Medos International SARL · Oct 2019
TSolution One Total Knee Application
K191369 · THINK Surgical, Inc. · Oct 2019
Premia Spine XL Instruments
K191854 · Premia Spine, Ltd. · Oct 2019
Intellijoint® Navigation System
K191507 · Intellijoint Surgical, Inc. · Oct 2019