Cleared Traditional

K130887 - S4C NAVIGATION INSTRUMENTS

K130887 is an FDA 510(k) clearance for S4C NAVIGATION INSTRUMENTS, manufactured by Aesculap Implant System, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K130887 · Aesculap Implant System, Inc. · Orthopedic device
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Aug 2013
Decision
137d
Days
Class 2
Risk

K130887 is an FDA 510(k) clearance for the S4C 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 System, Inc. (Center Valley, US). The FDA issued a Cleared decision on August 13, 2013 after a review of 137 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 Aesculap Implant System, Inc. devices

FDA 510(k) Submission Details - K130887

510(k) Number K130887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2013
Decision Date August 13, 2013
Days to Decision 137 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
15d slower than avg
Panel avg: 122d · This submission: 137d
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 K130887.
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
K140454 · Medtronic Sofamor Danek USA, Inc. · May 2014
ORTHOALIGN PLUS SYSTEM
K130387 · Orthalign, Inc. · Nov 2013
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
K131425 · Medtronic Navigation, Inc. · Aug 2013
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · Smith & Nephew, Inc. · Aug 2013
NAVIGATION PIN
K131130 · Evergreen Orthopedic Research Lab · Jul 2013
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
K124004 · Medtronic Navigation, Inc. · Mar 2013