Home / 510(k) Clearances / K243024

510(k) K243024

Cellbrick Knee Spacer by United Orthopedic Corporation — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2024
Date Received
September 27, 2024
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 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)
  • 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 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)