510(k) K133759

INTELLIJOINT HIP by Intellijoint Surgical, Inc. — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 23, 2014
Date Received: December 11, 2013
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.

Other clearances by Intellijoint Surgical, Inc.

K211876 — Intellijoint VIEW (November 12, 2021)
K191507 — Intellijoint® Navigation System (October 1, 2019)
K172849 — Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint (November 16, 2017)
K171525 — Intellijoint HIP Generation 2B System (October 30, 2017)
K162364 — Intellijoint HIP Generation 2A System (March 2, 2017)
K151364 — Intellijoint HIP(tm) System (December 28, 2015)

Other clearances for product code OLO

K260010 — TMINI® Miniature Robotic System (March 3, 2026)
K260222 — Mako Total Knee Application (February 25, 2026)
K252989 — POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set (February 20, 2026)
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)