Home / 510(k) Clearances / K203341

510(k) K203341

ACS LD Uni FB Knee System by Implantcast GmbH — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2021
Date Received
November 12, 2020
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 Implantcast GmbH

  • K252401 — implaFit® short stems (March 12, 2026)
  • K241944 — AGILON® XO Shoulder Replacement System (March 10, 2025)
  • K240391 — MUTARS® femoral stem cemented 160 mm and 200 mm (October 24, 2024)
  • K234044 — ACS® LD FB Knee System (September 6, 2024)
  • K240834 — EcoFit® short stem cementless cpTi (June 3, 2024)
  • K231657 — AGILON® XO Shoulder Replacement System (February 16, 2024)
  • K232371 — Actinia® hip stems (October 19, 2023)
  • K223103 — BethaLoc® stem cementless HA (June 20, 2023)
  • K222482 — AGILON XO Shoulder System (September 28, 2022)
  • K210678 — implaFit® hip stems (August 17, 2022)

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)