Home / 510(k) Clearances / K122985

510(k) K122985

COLUMBUS REVISION KNEE SYSTEM by Aesculap Implant System, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2012
Date Received
September 26, 2012
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 Aesculap Implant System, Inc.

  • K142707 — AIS Odontoid Fracture Fixation System (December 19, 2014)
  • K142150 — AIS MODULIFT VBR SYSTEM (October 29, 2014)
  • K133802 — AIS MODULIFT VBR SYSTEM (April 17, 2014)
  • K122783 — PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (October 30, 2013)
  • K130887 — S4C NAVIGATION INSTRUMENTS (August 13, 2013)
  • K123909 — AESCULAP CESPACE XP (April 15, 2013)
  • K130291 — S4 SPINAL SYSTEM (April 11, 2013)
  • K112551 — S4 SPINAL SYSTEM (November 21, 2011)
  • K101281 — VEGA KNEE SYSTEM (July 30, 2010)
  • K100147 — S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (July 23, 2010)

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)