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510(k) K200122

MOTO PFJ System by Medacta International S.A. — Product Code KRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2020
Date Received
January 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3540
Review Panel
OR
Submission Type

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  • K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System (June 14, 2018)
  • K160461 — Arthrex iBalance BiCompartmental Arthroplasty System (April 12, 2016)
  • K143543 — Prelude PF Patellae (January 30, 2015)
  • K123907 — PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST (September 3, 2013)
  • K111970 — KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT (February 23, 2012)
  • K082088 — MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II (October 22, 2008)
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