Home / 510(k) Clearances / K190122

510(k) K190122

Renovis A200 PS Knee System as part of the Renovis A200 Knee System by Renovis Surgical Technologies — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2019
Date Received
January 25, 2019
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 Renovis Surgical Technologies

  • K182007 — Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System (December 7, 2018)
  • K181655 — Renovis S180 Lateral Lumbar Interbody Fusion System (September 11, 2018)
  • K180502 — S128 Anterior Lumbar Interbody Fusion (ALIF) System (June 14, 2018)
  • K171543 — Renovis Surgical Hip Replacement System (November 16, 2017)
  • K170888 — Renovis S141 Lumbar Interbody Fusion System (August 8, 2017)
  • K153250 — Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System (March 16, 2016)
  • K152193 — Renovis Anterior Cervical Plate System (September 25, 2015)
  • K143647 — Renovis Surgical Hip Replacement System (May 11, 2015)
  • K143126 — Renovis S141 Lumbar Interbody Cage System (February 6, 2015)
  • K141676 — RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM (November 4, 2014)

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)