COLUMBUS TOTAL KNEE SYSTEM AS— 510(k) K071220

Clearance details

Applicant

Aesculap Implant Systems, Inc.

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2007-05-02

Decision date

2007-06-01

Decision

Substantially Equivalent

Clearance type

Special

Location

Center Valley, PA, US

• K260063 — GSPE Spacer2026-09-11
• K262293 — EVOLUTION MPX Total Knee System2026-09-10
• K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
• K262130 — ATTUNE Revision Knee System2026-09-04
• K253961 — SK Knee System2026-09-01

• K153629 — ArcadiusXP C Spinal System2016-05-25
• K132421 — AESCULAP PEEK XP SPINAL IMPLANT SYSTEM2014-01-22
• K123939 — S4 SPINAL SYSTEM2013-03-12
• K123352 — S4 SPINAL SYSTEM2012-12-12
• K111122 — AESCULAP SIBD XP SPINAL SYSTEM2011-08-04

Death

26

Injury

51,564

Malfunction

9,725

Other

9

Total

61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1481-2020 — AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.Class II·Terminated·Aesculap Implant Systems LLC·20200121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071220.