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510(k) K243656

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella by United Orthopedic Corporation — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2025
Date Received
November 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

Other clearances by United Orthopedic Corporation

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  • K252303 — Stem Extension Line (USTAR II System) (August 22, 2025)
  • K242315 — Resolve Modular Revision Hip Stem (May 1, 2025)
  • K243466 — Conformity Stem Extension Line, #0 (January 6, 2025)
  • K243024 — Cellbrick Knee Spacer (December 20, 2024)
  • K242249 — Conformity Stem Extension Line (August 30, 2024)
  • K221705 — U2 Total Knee System-PF+ (February 28, 2023)
  • K221149 — U-Motion II Acetabular System-Extension line (January 5, 2023)
  • K221675 — United U2 femoral head, 22mm delta ceramic head (November 4, 2022)
  • K222700 — Tibial baseplate, Tibial insert (October 6, 2022)

Other clearances for product code MBH

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  • K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing I (February 18, 2026)
  • K253239 — Active-V Total Knee System; World Total Knee System (December 23, 2025)
  • K253161 — Balanced Knee System TriMax Porous Femoral Components (December 19, 2025)
  • K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (October 31, 2025)
  • K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components (October 24, 2025)
  • K250980 — Physica System (Physica CR Porous Femoral components) (May 22, 2025)
  • K243768 — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (March 27, 2025)
  • K241597 — Freedom® Total Knee System - Porous Tibial Base Plate (February 13, 2025)