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510(k) K082088

MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II by Mako Surgical Corp. — Product Code KRR

K082088 is an FDA 510(k) premarket notification submitted by Mako Surgical Corp. for the device "MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II". The FDA issued a decision of Substantially Equivalent on October 22, 2008. The device falls under product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3540. Mako Surgical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2008
Date Received
July 24, 2008
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

Other clearances by Mako Surgical Corp.

  • K260222 — Mako Total Knee Application (February 25, 2026)
  • K250608 — Mako Total Knee Application (3.0); Hybrid Tip Pointer (April 25, 2025)
  • K243751 — Mako Total Hip Application 5.0 (March 5, 2025)
  • K242373 — Mako Shoulder Application (1.0) (November 7, 2024)
  • K241011 — Mako Total Knee Application (June 11, 2024)
  • K220930 — Restoris Multi-Compartmental Knee System (June 2, 2022)
  • K220459 — Mako Total Knee Application (April 15, 2022)
  • K193515 — Mako Total Knee Application (July 14, 2020)
  • K193128 — Mako Total Hip Application (February 2, 2020)
  • K191998 — Mako Total Hip Application, Mako Total Knee Application (September 24, 2019)

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)
  • 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)
  • K080029 — MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM (May 16, 2008)

FDA data resources