Cleared Traditional

K153700 - Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments

K153700 is an FDA 510(k) clearance for Aesculap Implant Systems (AIS) S4 Navig..., manufactured by Aesculap Implant Systems, LLC. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K153700 · Aesculap Implant Systems, LLC · Orthopedic device
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Jul 2016
Decision
198d
Days
Class 2
Risk

K153700 is an FDA 510(k) clearance for the Aesculap(R) Implant Systems (AIS) S4 Navigation 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 Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on July 8, 2016 after a review of 198 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 Aesculap Implant Systems, LLC devices

FDA 510(k) Submission Details - K153700

510(k) Number K153700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date July 08, 2016
Days to Decision 198 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
76d slower than avg
Panel avg: 122d · This submission: 198d
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 Peers - OLO Orthopedic Stereotaxic Instrument

All 433
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K153700.
Stryker OrthoMap Precision Knee system
K162341 · Stryker Leibinger GmbH & Co KG · Oct 2016
TSolution One Cup1 Surgical System
K162195 · THINK Surgical, Inc. · Sep 2016
Precision Screw
K160385 · Cryptych Pty, Ltd. · Jul 2016
Styrker OrthoMap Express Knee System
K153240 · Stryker Corporate · Jul 2016
Stealth-Midas System
K160713 · Medtronic Powered Surgical Solutions · May 2016
Navio
K160537 · Blue Belt Technologies, Inc. · May 2016