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510(k) K220930

Restoris Multi-Compartmental Knee System by Mako Surgical Corp. — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2022
Date Received
March 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
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)
  • 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)
  • K172301 — Mako Partial Knee Application (November 2, 2017)

Other clearances for product code HSX

  • K251771 — Cambridge Partial Knee (December 16, 2025)
  • K251834 — Persona Partial Knee (August 15, 2025)
  • K251618 — MOTO Partial Knee System Extension (July 24, 2025)
  • K251453 — Arthrex iBalance Partial Knee System (July 1, 2025)
  • K241260 — ACTIFY™ Unicondylar Knee System (December 6, 2024)
  • K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (October 30, 2024)
  • K242746 — OvertureTi Knee Resurfacing SystemTM (October 7, 2024)
  • K232114 — TRIBRID® Unicompartmental Knee System (April 4, 2024)
  • K221292 — Uni Knee Resurfacing System (March 10, 2023)
  • K212870 — TLC Unicompartmental Knee System (June 16, 2022)