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510(k) K163332

Apex Revision Knee System by Omnilife Science — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2017
Date Received
November 28, 2016
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 Omnilife Science

  • K201611 — Apex Knee System (April 2, 2021)
  • K172467 — OMNI ARC Anteverted Neck Hip Stem (December 21, 2017)
  • K171156 — OMNI Anseris Hip Stem (August 17, 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

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  • 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)