Distal Humeral Plates with Angular Stability

• • Ongoing Z-1602-2026 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

K080184 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K050852 Active Cleared 22 Jun 2005

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  Class II

  FDA 510(k) K063166 Active Cleared 22 Dec 2006

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

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• Connexx Locking Tibia Nail

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

  Class II

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• 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 are distal humeral plates with angular stability used for?

  These plates are designed to stabilize fractures of the distal humerus in the elbow of pediatric or adult patients. They are intended for intra-articular fractures, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

• What configurations are available for these plates?

  The plates are available in medial (8 hole) and dorsolateral (5 hole) configurations for both left and right use, allowing surgeons to select the appropriate plate based on the specific fracture pattern and surgical approach.

• Are these plates single-use or reusable?

  The device data does not specify whether these plates are single-use or reusable. As a fracture fixation system component, the reusability would depend on the hospital's sterilization protocols and the manufacturer's instructions for use.

• What regulatory clearance has been obtained for these plates?

  The distal humeral plates with angular stability have received FDA 510(k) clearance with the product code HRS, classified as substantially equivalent to predicate devices for fracture fixation of the distal humerus.