Fibula Plate Prolock with Angular Stability

• • Ongoing Z-1601-2026 FDA Class II ·initiated 23 Jan 2026

  Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

510(k) Number

K063672 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Claviculaplate with Angular Stablity Bone Plate System Open recall

  Class II

  FDA 510(k) K050852 Active Cleared 22 Jun 2005

• I.T.S. Pelvic Reconstruction System Open recall

  Class II

  FDA 510(k) K063166 Active Cleared 22 Dec 2006

• Fr.o.h. Calcaneus Repair System Open recall

  Class II

  FDA 510(k) K051642 Active Cleared 22 Aug 2005

• Connexx Locking Tibia Nail

  Class II

  FDA 510(k) K080706 Active Cleared 9 Jun 2008

• I.T.S. Lrs Locking Reconstruction System Open recall

  Class II

  FDA 510(k) K093868 Active Cleared 5 Aug 2010

• Epiphysis Screw

  Class II

  FDA 510(k) K043410 Active Cleared 24 Feb 2005

See all devices from I.T.S. Implantat-Technologie-Systeme GmbH →