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Synthes TI-15 Mo Locking Distal Radius Plating System

by Synthes (Usa) 510(k)

Active United States

510(k) K031725

Overview

The Synthes Ti-15 Mo Locking Distal Radius Plating System is an orthopedic appliance classified as a fixation nail/blade/plate combination, designed for multi-component stabilization. It is intended for the internal fixation of complex intra-articular and extra-articular fractures, as well as osteotomies of the distal radius. Constructed with titanium-molybdenum alloy, the system provides locking mechanisms to enhance stability during bone healing. Its modular design allows for customizable fixation tailored to specific fracture patterns.

This device is supplied as a reusable surgical implant and is intended for use in orthopedic procedures within an operating room setting. The plating system requires sterile preparation and is regulated under FDA 510(k) clearance (K031725) via the Traditional pathway, classified under product code KTT. It is not intended for MRI use and must be handled according to standard orthopedic surgical protocols. Storage and handling follow manufacturer guidelines to maintain sterility and structural integrity.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031725 Date24 Jun 2003ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Synthes Ti-15 Mo Locking Distal Radius Plating System used for?

    This system is designed for internal fixation of complex intra-articular and extra-articular fractures of the distal radius, as well as osteotomies. Its modular titanium-molybdenum alloy construction allows for adjustable locking mechanisms to stabilize bone fragments during healing, ensuring tailored support for various fracture patterns.

  • Is the Ti-15 Mo Locking Distal Radius Plating System reusable or single-use?

    The system is explicitly supplied as a reusable surgical implant. It must be prepared and handled according to sterile surgical protocols to maintain integrity and safety for repeated use in orthopedic procedures.

  • What materials is the plating system made from, and why does it matter?

    The system is constructed from a titanium-molybdenum alloy, which provides a balance of strength, corrosion resistance, and biocompatibility. This material choice reduces the risk of allergic reactions or implant failure while ensuring durability during bone healing.

  • How should the Ti-15 Mo Locking Distal Radius Plating System be stored?

    Storage must follow manufacturer guidelines to preserve sterility and structural integrity. The system is intended for use in an operating room setting, so it should be kept in a clean, dry environment away from contaminants until sterile preparation for surgery.

  • Can this plating system be used in MRI procedures?

    No, the Synthes Ti-15 Mo Locking Distal Radius Plating System is explicitly not intended for MRI use. Its metallic composition could interfere with imaging and pose safety risks in magnetic resonance environments.