Home / 510(k) Clearances / K200709

510(k) K200709

Kyocera Bipolar Hip System by Kyocera Medical Technologies, Inc. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2020
Date Received
March 18, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

Other clearances by Kyocera Medical Technologies, Inc.

  • K242045 — Initia T3 Acetabular Hemispherical Shell System (April 10, 2025)
  • K242928 — Tesera-k SC System (April 10, 2025)
  • K242771 — Tesera-k PL System and Tesera-k XL System (March 20, 2025)
  • K243295 — Initia Knee System (January 13, 2025)
  • K243015 — Skyway Anterior Cervical Plate System (November 5, 2024)
  • K232114 — TRIBRID® Unicompartmental Knee System (April 4, 2024)
  • K230808 — PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System (April 21, 2023)
  • K223105 — Tesera-K SC System (December 22, 2022)
  • K212980 — Tesera-k ALIF System (January 7, 2022)
  • K212070 — KMTI S141 Lumbar Interbody Fusion System (August 30, 2021)

Other clearances for product code KWY

  • K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip) (August 25, 2025)
  • K231526 — CORAIL Cemented Femoral Stem (December 19, 2023)
  • K223441 — SpaceFlex Acetabular Cup (March 23, 2023)
  • K221794 — Vario-Cup System (July 20, 2022)
  • K220492 — COPAL exchange G hip spacer (March 23, 2022)
  • K192236 — Fitmore Hip Stem (November 5, 2019)
  • K191016 — COPAL exchange G Hip and Knee Spacers (November 1, 2019)
  • K191297 — iNSitu Bipolar Hip System (September 17, 2019)
  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)
  • K183114 — Corin BiPolar-i (June 5, 2019)