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510(k) K213673

b-ONE MOBIO Total Knee System by B-One Ortho, Corp. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2022
Date Received
November 22, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
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)
  • 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)
  • K173380 — b-ONE® Total Hip System (August 30, 2018)

Other clearances for product code JWH

  • K253793 — Materialise TKA Guide System (January 6, 2026)
  • K252974 — EMPOWR Knee (December 19, 2025)
  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251241 — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (July 2, 2025)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)