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510(k) K090763

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

K090763 is an FDA 510(k) premarket notification submitted by Mako Surgical Corporation for the device "RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM". The FDA issued a decision of Substantially Equivalent on June 17, 2009. The device falls under product code NPJ (Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Mako Surgical Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2009
Date Received
March 23, 2009
Clearance Type
Traditional
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)
  • 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)
  • K082172 — MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM (November 28, 2008)

Other clearances for product code NPJ

  • K150307 — RESTORIS Multicompartmental Knee System (March 10, 2015)
  • K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (December 10, 2013)
  • K093513 — IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (December 16, 2009)
  • K093056 — SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (December 15, 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)

FDA data resources