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510(k) K160461

Arthrex iBalance BiCompartmental Arthroplasty System by Arthrex, Inc. — Product Code KRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2016
Date Received
February 19, 2016
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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  • K253727 — Syndesmosis TightRope PRO (December 22, 2025)
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  • K251994 — Arthrex Synergy Vision Imaging System (October 16, 2025)

Other clearances for product code KRR

  • K231253 — Overture Orthopaedics Patellofemoral System (July 7, 2023)
  • K221048 — Episealer Patellofemoral System (December 23, 2022)
  • K211303 — Avon Patello-femoral Joint Prosthesis (June 4, 2021)
  • K200122 — MOTO PFJ System (April 20, 2020)
  • K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System (June 14, 2018)
  • 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)