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510(k) K181280

Patello-Femoral Wave (Kahuna) Arthroplasty System by Arthrosurface, Inc. — Product Code KRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2018
Date Received
May 15, 2018
Clearance Type
Special
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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  • K161539 — Arthrosurface Bone Screws (June 30, 2016)
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Other clearances for product code KRR

  • K231253 — Overture Orthopaedics Patellofemoral System (July 7, 2023)
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  • K211303 — Avon Patello-femoral Joint Prosthesis (June 4, 2021)
  • K200122 — MOTO PFJ System (April 20, 2020)
  • 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)
  • K080029 — MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM (May 16, 2008)