510(k) K133039

RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM by Mako Surgical Corporation — Product Code NPJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 10, 2013
Date Received: September 26, 2013
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class: Class II
Regulation Number: 888.3560
Review Panel: OR
Submission Type

The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.

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)
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 NPJ

K150307 — RESTORIS Multicompartmental Knee System (March 10, 2015)
K093513 — IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (December 16, 2009)
K093056 — SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (December 15, 2009)
K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM (June 17, 2009)
K070849 — DEPUY GCK FEMORAL AND TIBIAL COMPONENTS (June 26, 2007)
K061648 — DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (September 11, 2006)
K061569 — SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (July 6, 2006)
K053488 — CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (March 9, 2006)
K052917 — STRYKER COMPARTMENTAL KNEE SYSTEM (December 27, 2005)
K052265 — SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (December 27, 2005)