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510(k) K141989

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

K141989 is an FDA 510(k) premarket notification submitted by Mako Surgical Corporation for the device "MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM". The FDA issued a decision of Substantially Equivalent on November 13, 2014. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Mako Surgical Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2014
Date Received
July 22, 2014
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)
  • K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (December 10, 2013)
  • K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM (June 6, 2012)
  • 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)

Other clearances for product code OLO

  • K261852 — OTS Hip (July 1, 2026)
  • K253921 — VERTICALE® Navigation Instruments (June 26, 2026)
  • K260480 — VELYS™ Robotic-Assisted Solution (June 25, 2026)
  • K260369 — Dynamis Robotic Surgical System (June 20, 2026)
  • K261665 — CORUS™ Navigation System-GN (June 18, 2026)
  • K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (June 2, 2026)
  • K261060 — Navigated LLIF Impactable Tracker (May 29, 2026)
  • K254157 — CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (May 26, 2026)
  • K260329 — Ion-C Navigation Instruments (May 22, 2026)
  • K260582 — ROSA® Shoulder System (May 21, 2026)

FDA data resources