510(k) K121064

MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM by Mako Surgical Corporation — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 6, 2012
Date Received: April 6, 2012
Clearance Type: Special
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 Mako Surgical Corporation

K142530 — Partial Knee Application (PKA) (September 16, 2015)
K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM (March 20, 2015)
K141989 — MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM (November 13, 2014)
K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (December 10, 2013)
K112507 — RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM (March 1, 2012)
K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM (June 17, 2009)
K082172 — MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM (November 28, 2008)

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K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
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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)