Home / 510(k) Clearances / K201611

510(k) K201611

Apex Knee System by Omnilife Science — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2021
Date Received
June 15, 2020
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 Omnilife Science

  • K172467 — OMNI ARC Anteverted Neck Hip Stem (December 21, 2017)
  • K171156 — OMNI Anseris Hip Stem (August 17, 2017)
  • K163332 — Apex Revision Knee System (April 26, 2017)
  • K153437 — Apex Revision Knee System (December 21, 2015)
  • K133381 — OMNI ARC MONOBLOCK HIP STEM (March 13, 2014)
  • K062489 — APEX HCLA ACETABULAR CUP LINERS (August 15, 2007)

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)