Home / 510(k) Clearances / K120955

510(k) K120955

COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM by Aesculap Implant Systems, LLC — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2012
Date Received
March 30, 2012
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 Aesculap Implant Systems, LLC

  • K213871 — Ennovate Cervical Spinal and Occiput System (July 1, 2022)
  • K210963 — ENNOVATE Spinal System (July 19, 2021)
  • K180433 — ENNOVATE® (April 26, 2018)
  • K162134 — ENNOVATE Spinal System (December 14, 2016)
  • K153700 — Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments (July 8, 2016)
  • K153629 — ArcadiusXP C Spinal System (May 25, 2016)
  • K153396 — Aesculap OrthoPilot Next Generation (May 16, 2016)
  • K151938 — S4 Cervical Spinal and Occiput Systems (October 21, 2015)
  • K151056 — Aesculap T-Space PEEK and XP Spinal System (August 13, 2015)
  • K150544 — Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System (May 29, 2015)

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)