Cleared Traditional

K182721 - Choice Spine Navigation System

K182721 is the FDA 510(k) clearance for Choice Spine Navigation System by Choicespine, LP. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K182721 · Choicespine, LP · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
102d
Days
Class 2
Risk

K182721 is an FDA 510(k) clearance for the Choice Spine Navigation System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Choicespine, LP (Knoxville, US). The FDA issued a Cleared decision on January 8, 2019 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 Choicespine, LP devices

Submission Details

510(k) Number K182721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date January 08, 2019
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Empirical Testing Corp
Meredith Lee May

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 352
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K182721.
ROSA ONE Spine application
K182848 · Medtech S.A · Mar 2019
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
K183196 · Stryker Corporation · Feb 2019
ROSA Knee System
K182964 · Orthosoft Inc. (d/b/a) Zimmer CAS · Jan 2019
BridalVeil Navigated Instruments
K182982 · Astura Medical · Jan 2019
Brainlab Compatible K2M Navigation Instruments
K181890 · K2m · Nov 2018
Mazor X System (Mazor X Stealth Edition)
K182077 · Mazor Robotics , Ltd. · Nov 2018