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Aevumed FENIX Suture Anchor

by Aevumed, Inc. 510(k)

Active United States

510(k) K254306

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK254306 Date4 Mar 2026ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Aevumed FENIX Suture Anchor is a medial row all-suture anchor designed for suture or tissue fixation in orthopedic procedures. It features a self-cinching mechanism and self-punching capability that eliminates the need for pilot holes, enabling reliable deployment and consistent pullout strength during rotator cuff repair and other joint fixation applications.

This device is supplied as a sterile, single-use implant intended for use in surgical settings including the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. It has received FDA 510(k) clearance (K254306) and is regulated under product code MBI with advisory committee classification OR (Orthopedic).

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Questions

AI-generated answers, 25 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 is the Aevumed FENIX Suture Anchor used for?

    The Aevumed FENIX Suture Anchor is designed for suture or tissue fixation in orthopedic procedures, particularly rotator cuff repair and other joint fixation applications in the shoulder, knee, ankle, hand, wrist, elbow, and hip, due to its all-suture construction and self-punching capability that eliminates the need for pilot holes.

  • How is the Aevumed FENIX Suture Anchor supplied and is it reusable?

    The device is supplied as a sterile, single-use implant, meaning it is intended for one procedure only and must be discarded after use; reusing it could compromise sterility and mechanical integrity, posing risks to patient safety.

  • What regulatory pathway was used for the Aevumed FENIX Suture Anchor?

    The Aevumed FENIX Suture Anchor received FDA 510(k) clearance under submission number K254306, indicating it was found substantially equivalent to a legally marketed predicate device, and is regulated under product code MBI with Orthopedic advisory committee review.