Cleared Traditional

K172517 - SeaSpine Navigation System

K172517 is the FDA 510(k) clearance for SeaSpine Navigation System by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K172517 · SeaSpine Orthopedics Corporation · Orthopedic device
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May 2018
Decision
263d
Days
Class 2
Risk

K172517 is an FDA 510(k) clearance for the SeaSpine 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 SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on May 11, 2018 after a review of 263 days - an extended review cycle.

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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K172517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2017
Decision Date May 11, 2018
Days to Decision 263 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
141d slower than avg
Panel avg: 122d · This submission: 263d
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 Peers - OLO Orthopedic Stereotaxic Instrument

All 364
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K172517.
NuVasive Pulse System
K180038 · Nu Vasive, Incorporated · Jun 2018
Navigation Instruments
K180690 · Globus Medical, Inc. · Jun 2018
Navigated INFINITY Instruments
K181111 · Medtronic Sofamor Danek USA, Inc. · May 2018
ADAPT for Gamma3
K173946 · Stryker GmbH · May 2018
7D Surgical System
K180352 · 7D Surgical, Inc. · May 2018
Spineology Navigation Instruments
K180796 · Spineology, Inc. · May 2018