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Xtreme-Loop

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191053

by Xiros Ltd

Identifiers

510(k) Number
K191053 FDA 510(k)
FDA Product Code
MBI 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 Xtreme-Loop is an orthopedic device classified under product code MBI, designed as a suture anchor or loop system for securing soft tissue to bone. It employs a titanium alloy construction with ultra-high-molecular-weight polyethylene (UHMWPE) components, providing mechanical fixation in orthopedic procedures.

Supplied sterile and intended for single-use, the Xtreme-Loop is regulated under FDA 510(k) clearance (K191053) and is substantively equivalent to a referenced orthopedic device. It is manufactured by Xiros Ltd. in Leeds, UK, and requires appropriate surgical settings for implantation, adhering to standard orthopedic sterilization and handling 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 Xiros Ltd Stephen Seed Compliance Director Springfield House, Xtreme-Loop (K191053) — FDA 510 (k) | Innolitics, PDF Xiros Ltd. Steve Curran Compliance Director Springfield House Lane ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Xiros Ltd
FDA Applicant
Xiros, Ltd.

Sources (1)

  • FDA 510(k) K191053 24 fields · synced Sep 19, 2026