Home / 510(k) Clearances / K150410

510(k) K150410

RESTORIS POROUS PARTIAL KNEE SYSTEM by Mako Surgical Corporation — Product Code HRY

K150410 is an FDA 510(k) premarket notification submitted by Mako Surgical Corporation for the device "RESTORIS POROUS PARTIAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 20, 2015. The device falls under product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3530. Mako Surgical Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2015
Date Received
February 18, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
Review Panel
OR
Submission Type

Other clearances by Mako Surgical Corporation

  • K142530 — Partial Knee Application (PKA) (September 16, 2015)
  • K141989 — MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM (November 13, 2014)
  • 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 HRY

  • K193549 — SIGMA High Performance (HP) Partial Knee System (April 16, 2020)
  • K190633 — NanoOrtho NanoKnee® System (December 20, 2019)
  • K152631 — MPO Total Knee Systems MR Labeling (March 23, 2016)
  • K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (March 28, 2014)
  • K131167 — UNIVATION (October 17, 2013)
  • K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) (October 22, 2012)
  • K110415 — SIGNATURE PLANNER / SIGNATURE GUIDES (May 16, 2011)
  • K100973 — EVOLUTION UNICONDYLAR KNEE SYSTEM (August 10, 2010)
  • K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (October 3, 2008)
  • K081293 — UNIVATION UNICONDYLAR KNEE SYSTEM (September 22, 2008)

FDA data resources