Skip to content

MRS-Titan

by Rotec Medizintechnik GmbH

510(k) K992359

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992359 Date18 Feb 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MRS-Titan is a patient-matched modular revision acetabular system designed for hip arthroplasty. It is classified as a revision acetabular component, intended to address bone defects and fractures in primary hip arthroplasty patients. The modular design allows for customised fixation to accommodate complex anatomical variations. This device is specifically engineered to provide stable fixation in revision surgeries and cases involving significant bone loss.

The MRS-Titan system is supplied as a modular acetabular component for surgical use in orthopaedic revision procedures. It is intended for single-use and requires sterile handling, adhering to standard surgical protocols. The system is authorised under FDA 510(k) clearance (K992359) and falls under the product code LZO for orthopaedic devices. No specific MRI safety information is provided, and storage conditions follow standard medical device guidelines for orthopaedic implants.

Other devices from Rotec Medizintechnik GmbH

  • MRP-Titan

    Class II

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MRS-Titan designed for in hip revision surgeries?

    The MRS-Titan is a modular revision acetabular system specifically engineered for hip arthroplasty revision procedures. It is intended to address bone defects and fractures in patients who have undergone primary hip arthroplasty. Its modular design allows for customised fixation, accommodating complex anatomical variations and providing stable support in cases involving significant bone loss.

  • How is the MRS-Titan system supplied and what are its handling requirements?

    The MRS-Titan system is supplied as a modular acetabular component for surgical use in orthopaedic revision procedures. It is intended for single-use only, meaning it must be handled under sterile conditions to comply with standard surgical protocols. This ensures patient safety and device integrity during the procedure.

  • Is the MRS-Titan system reusable or single-use?

    The MRS-Titan system is explicitly designed for single-use. This designation aligns with standard medical device practices for orthopaedic implants to maintain sterility and reduce infection risks during surgical procedures.

  • Are there specific storage guidelines for the MRS-Titan?

    Storage for the MRS-Titan follows standard medical device guidelines for orthopaedic implants. While no unique conditions are specified, it is critical to adhere to manufacturer-recommended storage practices to preserve the device’s integrity and functionality until use.

  • Does the MRS-Titan have any known MRI safety information?

    No specific MRI safety information is provided for the MRS-Titan. Clinicians should consult additional resources or manufacturer guidelines before considering MRI use with this device to avoid potential risks.