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I.T.S. Hand Locking Plates System - HLS

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142418

by I.T.S. GmbH

Identifiers

510(k) Number
K142418 FDA 510(k)
FDA Product Code
HRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The I.T.S. Hand Locking Plates System - HLS is an orthopedic device classified as an osteosynthesis plate designed for internal fixation of hand fractures. It stabilizes aligned bone fragments to promote proper healing through mechanical compression and secure screw fixation, with adjustable locking configurations for enhanced versatility.

This system is supplied sterile and intended for single-use in orthopedic surgery settings. It includes various plate types with freely selectable hole configurations, allowing surgeons to choose between locking and non-locking screws (excluding compression and oblong holes). The device holds FDA 510(k) clearance (K142418) and is regulated under the Traditional 510(k) pathway, with no third-party involvement. Storage and handling must comply with sterile surgical instrument protocols.

Frequently asked questions

What types of hand fractures is this plate system designed to stabilize, and how does it work to promote healing?

The I.T.S. Hand Locking Plates System (HLS) is specifically designed for internal fixation of hand fractures. It stabilizes aligned bone fragments through mechanical compression and secure screw fixation, allowing surgeons to choose between locking and non-locking screws (excluding compression or oblong holes) for adjustable configurations. This versatility helps maintain proper bone alignment during healing, reducing the risk of displacement.

Is this device reusable, or is it intended for single-use only? How should it be handled to maintain sterility?

The I.T.S. Hand Locking Plates System is supplied sterile and explicitly intended for single-use in orthopedic surgery. To maintain sterility, it must be stored and handled according to standard sterile surgical instrument protocols, ensuring no contamination occurs before use.

What makes this system different from traditional hand fracture plates, particularly in terms of screw options?

Unlike traditional plates, the HLS system offers freely selectable hole configurations, allowing surgeons to choose between locking and non-locking screws (excluding compression or oblong holes). This flexibility provides enhanced versatility in securing bone fragments, adapting to different fracture patterns without requiring compression or oblong screw options.

How is this device regulated, and what does the FDA clearance (K142418) mean for its use in clinical settings?

The I.T.S. Hand Locking Plates System holds FDA 510(k) clearance (K142418) under the Traditional 510(k) pathway, meaning it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms that the device meets regulatory standards for safety and effectiveness as intended for internal fixation of hand fractures, though it does not imply any specific clinical indication beyond its approved use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hand Locking Plates System (HLS) | ITS Implant - USA, I.T.S. Hand Locking Plates System - HLS (K142418) — FDA 510 (k ..., HLS - I.T.S. - PDF Catalogs | Technical Documentation, Class 2 Device Recall HLS Hand Locking Plates System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
I.T.S. GmbH

Sources (1)

  • FDA 510(k) K142418 24 fields · synced Sep 19, 2026