Home / 510(k) Clearances / K190100

510(k) K190100

USTAR II System by United Orthopedic Corporation — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2019
Date Received
January 22, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

Other clearances by United Orthopedic Corporation

  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K252303 — Stem Extension Line (USTAR II System) (August 22, 2025)
  • K243656 — U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (July 31, 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)

Other clearances for product code KRO

  • K252898 — Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patell (December 15, 2025)
  • K252303 — Stem Extension Line (USTAR II System) (August 22, 2025)
  • K251665 — Triathlon® Hinge Knee System (July 25, 2025)
  • K242871 — ATTUNE™ Revision Hinge Knee (November 21, 2024)
  • K240043 — EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Fe (April 1, 2024)
  • K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation S (March 21, 2024)
  • K230563 — EVOLUTION® Hinge Knee System (September 27, 2023)
  • K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (May 19, 2023)
  • K223069 — Modular Rotating Hinge Knee Systems and Compatible Components (April 21, 2023)
  • K223528 — Triathlon® Hinge Knee System (January 20, 2023)