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MRP-Titan

by Rotec Medizintechnik GmbH

510(k) K992403

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 NumberK992403 Date21 Jan 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  • Withdrawn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, 19 Sep 2026

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

The MRP-Titan is an orthopedic device classified under product code LZO, designed for internal fixation of long bone fractures. It features a modular system for securing bone fragments with screws and plates, enabling stable alignment during the healing process.

This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is regulated under FDA 510(k) clearance (K992403) via the Traditional pathway, with no specific MRI safety labeling indicated. Storage and handling must comply with sterile medical device protocols as per manufacturer guidelines.

Other devices from Rotec Medizintechnik GmbH

  • MRS-Titan

    Class II

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of long bone fractures is the MRP-TITAN designed to stabilize, and how does its modular system work?

    The MRP-TITAN is an internal fixation device classified under product code LZO, specifically designed for securing long bone fractures. Its modular system allows surgeons to combine screws and plates in various configurations to achieve stable alignment of bone fragments during the healing process. This flexibility helps tailor the fixation to the specific fracture pattern and anatomical location.

  • Is the MRP-TITAN intended for reuse, or is it meant to be used only once per patient?

    The MRP-TITAN is explicitly supplied sterile and intended for single-use in orthopedic surgical settings. This ensures patient safety and compliance with sterile medical device protocols, as reuse could compromise sterility and integrity.

  • How should the MRP-TITAN be stored to maintain its sterility and functionality?

    The MRP-TITAN must be stored and handled according to sterile medical device protocols outlined by the manufacturer. Since it is supplied sterile and single-use, proper storage conditions—such as sealed packaging, controlled humidity, and protection from contamination—are critical to preserve its sterility and performance until use.

  • What regulatory pathway was followed for FDA clearance of the MRP-TITAN, and what does this mean for its use?

    The MRP-TITAN received FDA clearance via the Traditional 510(k) pathway (K992403), with a decision of Substantially Equivalent (SESE) under the Orthopedic (OR) advisory committee. This means the device was determined to be comparable to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for internal fixation of long bone fractures in orthopedic surgery.