Home / 510(k) Clearances / K253357

510(k) K253357

b-ONE® Bipolar Head by B-One Ortho, Corp. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2026
Date Received
September 30, 2025
Clearance Type
Traditional
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 B-One Ortho, Corp.

  • K240528 — b-ONE® Total Hip System (November 15, 2024)
  • K222431 — b-ONER MOBIO Total Knee System (October 6, 2022)
  • K213673 — b-ONE MOBIO Total Knee System (January 21, 2022)
  • K212912 — OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Sutur (November 4, 2021)
  • K210483 — MOBIO Total Knee System (April 21, 2021)
  • K202768 — KOSMO Femoral Stem (April 1, 2021)
  • K202429 — Mobio Total Knee System (October 23, 2020)
  • K182705 — Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups (February 14, 2019)
  • K183025 — MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO (January 28, 2019)
  • K180446 — b-ONE Total Knee System (October 12, 2018)

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)
  • K200709 — Kyocera Bipolar Hip System (April 17, 2020)
  • 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)