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Titanium Suture Anchor

by Mtp Solutions, LLC

510(k) K133229

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 NumberK133229 Date30 Jan 2014ClearedStatusActive

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  • Withdrawn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
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
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 Titanium Suture Anchor is a nondegradable fixation device designed for soft tissue attachment. Classified as a fastener under FDA regulation 888.3040, it is intended for securing sutures or tissues in orthopedic applications, providing stable fixation in joints such as the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder. Constructed from titanium, it offers durability and biocompatibility for long-term use within the body.

Supplied as a sterile, single-use device, the Titanium Suture Anchor is intended for surgical use in orthopedic procedures. It is regulated under FDA 510(k) clearance (K133229) and falls under the product code MBI, classified as a Class II device. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use. No additional regulatory approvals beyond the stated 510(k) clearance are implied.

Other devices from Mtp Solutions, LLC

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 Titanium Suture Anchor used for?

    The Titanium Suture Anchor is designed for securing sutures or tissues in orthopedic applications. It provides stable fixation in joints such as the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder. Its durable titanium construction ensures long-term biocompatibility and reliability within the body.

  • Is the Titanium Suture Anchor single-use or reusable?

    The Titanium Suture Anchor is supplied as a sterile, single-use device. This ensures patient safety and maintains sterility for surgical procedures, preventing cross-contamination or degradation from repeated use.

  • What materials is the Titanium Suture Anchor made from?

    The device is constructed from titanium, a material chosen for its durability, biocompatibility, and resistance to corrosion. This makes it suitable for long-term fixation within the body without adverse reactions.

  • How should the Titanium Suture Anchor be stored?

    The Titanium Suture Anchor must be stored and handled according to sterile medical device protocols. Proper storage ensures the device remains intact and uncontaminated prior to use, maintaining its integrity for surgical procedures.

  • What regulatory clearance does the Titanium Suture Anchor have?

    The Titanium Suture Anchor holds FDA 510(k) clearance under the product code MBI, classified as a Class II device. It was determined to be substantially equivalent to a legally marketed predicate device and is regulated under FDA regulation 888.3040 for fasteners.