← Back to catalogue

CrossTIE Intraosseous Fixation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151270

by Crossroads Extremity Systems, LLC

Identifiers

510(k) Number
K151270 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CrossTIE Intraosseous Fixation System is an orthopedic device classified as an intraosseous fixation implant. It is designed for the stabilization of bone fragments in toe fractures, fusions, and osteotomies, including conditions such as hammertoe, claw toe, mallet toe, and interdigital fusions. Constructed for use in the phalanges of the toes, the system provides mechanical support to promote proper alignment and healing of bony structures.

This device is supplied sterile and intended for single-use in surgical settings. It is intended for use by qualified healthcare professionals in orthopedic procedures. The system is regulated under FDA 510(k) clearance (K151270) and falls under the product code HWC. No specific MRI safety information is provided, and storage conditions should follow standard sterile surgical instrument protocols.

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: PDF IFU - CrossRoads Extremity, CrossTie Intraosseous Fixation System - medical-xprt.com, CROSSROADS EXTREMITY SYSTEMS 1443-2510 CrossTIE™, CrossTIE Intraosseous Fixation System (K151270) — FDA 510(k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Crossroads Extremity Systems, LLC

Sources (1)

  • FDA 510(k) K151270 24 fields · synced Sep 20, 2026