Olecranonplate with Angular Stability

• • Ongoing Z-1597-2026 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

K052368 ↗

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 →

• What is the Olecranon Plate with Angular Stability used for?

  This device is designed to stabilize and support the olecranon region of the elbow during orthopedic procedures, particularly for fracture fixation. Its angular stability and threaded holes ensure secure attachment to bone, providing rigid internal fixation where anatomical alignment and strength are critical.

• How is the Olecranon Plate with Angular Stability supplied and prepared for use?

  The plate is supplied sterile and intended for single-use only. It does not require additional sterilization or reprocessing after implantation—it is meant to be used once in the operating room under aseptic conditions by qualified orthopedic professionals.

• What hole configurations are available, and how do they accommodate different cases?

  The plate offers three hole configurations: 8, 10, and 12 holes. These variations allow surgeons to select the optimal length and screw placement for the patient’s anatomy and surgical approach, ensuring flexibility in fixation strategies.

• Is the device reusable, or is it meant for one-time surgical use?

  The Olecranon Plate with Angular Stability is explicitly designed as a single-use implant. Its sterile packaging and titanium construction are intended for one surgical procedure only, eliminating the need for reprocessing or reuse.

• How should the device be stored before use?

  The plate should be stored in its original sterile packaging, protected from contamination and physical damage. It must remain in a clean, controlled environment (e.g., operating room or sterile supply area) until immediately before use to maintain sterility.