Pigalileo Total Knee Replacement (Tkr) System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K061362 ↗

FDA Product Code

HAW

FDA applicant

Plus Orthopedics AG

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Rt-Plus Modular Cemented Knee Components

  Class II

  FDA 510(k) K003504 Active Cleared 11 May 2001

• Plus Bipolar Prosthesis Cocrmo

  Class II

  FDA 510(k) K982447 Active Cleared 25 Nov 1998

• Tc-Plus Porous Tibial Components

  Class II

  FDA 510(k) K011288 Active Cleared 24 May 2001

• Modification to Slim Gliding Nail System

  Class II

  FDA 510(k) K033763 Active Cleared 18 Dec 2003

• Uc-Plus Solution Unicondylar Knee

  Class II

  FDA 510(k) K032052 Active Cleared 25 Jul 2003

• Pe-Plus Acetabular Cup

  Class II

  FDA 510(k) K992153 Active Cleared 23 Sep 1999

See all devices from Plus Orthopedics →