Home / 510(k) Clearances / K233093

510(k) K233093

Balanced Knee® System TriMax PS Plus Tibial Insert by Ortho Development Corporation — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2023
Date Received
September 26, 2023
Clearance Type
Special
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 Ortho Development Corporation

  • K211086 — The Progen™ Trochanteric Nail System (December 21, 2021)
  • K211471 — Balanced Knee System Uni (December 16, 2021)
  • K203023 — Pisces Spinal System (July 14, 2021)
  • K200281 — The Gecko Spinal System (March 31, 2020)
  • K182085 — Balanced Knee Revision System Trabecular Tibial Cone Augments (October 31, 2018)
  • K181569 — BKS Revision Sleeves System (October 12, 2018)
  • K180743 — Balanced Knee Revision System - Offset Junction Box (June 20, 2018)
  • K173951 — Legend Acetabular Liners (May 30, 2018)
  • K171249 — Entrada™ hip stem (August 24, 2017)
  • K162995 — Ibis® Pedicle Screw System (March 30, 2017)

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)