COLUMBUS REVISION KNEE SYSTEM— 510(k) K083772

Clearance details

Applicant

Aesculap Implant System, Inc.

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2008-12-18

Decision date

2009-06-04

Decision

Substantially Equivalent

Clearance type

Traditional

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

• K142707 — AIS Odontoid Fracture Fixation System2014-12-19
• K142150 — AIS MODULIFT VBR SYSTEM2014-10-29
• K133802 — AIS MODULIFT VBR SYSTEM2014-04-17
• K122783 — PLASMAFIT ACETABULAR CUP AND VITELENE INSERT2013-10-30
• K130887 — S4C NAVIGATION INSTRUMENTS2013-08-13

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-1482-2020 — COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z 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
• Z-1043-2016 — Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.Class II·Terminated·Aesculap, Inc.·20151130
• Z-0492-2014 — Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7Class II·Terminated·Aesculap, Inc.·20130919
• Z-1793-2012 — Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contractureClass II·Terminated·Aesculap Implant Systems·20120221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083772.