Cleared Traditional

K181606 - Precision Spine Navigation Instrumentation

K181606 is an FDA 510(k) clearance for Precision Spine Navigation Instrumentation, manufactured by Precision Spine, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 465-day FDA review.

K181606 · Precision Spine, Inc. · Orthopedic device
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Sep 2019
Decision
465d
Days
Class 2
Risk

K181606 is an FDA 510(k) clearance for the Precision Spine Navigation Instrumentation. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on September 27, 2019 after a review of 465 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Precision Spine, Inc. devices

FDA 510(k) Submission Details - K181606

510(k) Number K181606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2018
Decision Date September 27, 2019
Days to Decision 465 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
343d slower than avg
Panel avg: 122d · This submission: 465d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLO Device Classification - Class 2, Special Controls

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 Consulting
Meredith 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 370
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K181606.
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
Mako Total Hip Application, Mako Total Knee Application
K191998 · Mako Surgical Corp. · Sep 2019
INTAI Surgery Navigation System
K180523 · Intai Technology Corporation · Sep 2019
Spine & Trauma Navigation
K183605 · Brainlab AG · Aug 2019