510(k) K153396

Aesculap OrthoPilot Next Generation by Aesculap Implant Systems, LLC — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 16, 2016
Date Received: November 24, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Orthopedic Stereotaxic Instrument
Device Class: Class II
Regulation Number: 882.4560
Review Panel: OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

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K210963 — ENNOVATE Spinal System (July 19, 2021)
K180433 — ENNOVATE® (April 26, 2018)
K162134 — ENNOVATE Spinal System (December 14, 2016)
K153700 — Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments (July 8, 2016)
K153629 — ArcadiusXP C Spinal System (May 25, 2016)
K151938 — S4 Cervical Spinal and Occiput Systems (October 21, 2015)
K151056 — Aesculap T-Space PEEK and XP Spinal System (August 13, 2015)
K150544 — Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System (May 29, 2015)
K141694 — AESCULAP ORTHOPILOT NEXT GENERATION (February 24, 2015)

Other clearances for product code OLO

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K254148 — VERTICALE GPS Instruments (February 19, 2026)
K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For U (February 19, 2026)
K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application (February 12, 2026)
K252873 — Q Interbody Instruments (February 6, 2026)
K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) (February 6, 2026)
K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)