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Genesys PressFT Suture Anchor

by Linvatec Corporation d/b/a ConMed Linvatec

510(k) K121890

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121890↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Special NumberK121890 Date22 Aug 2012ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Overview

AI-generated summary, 18 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 Genesys PressFT Suture Anchor is a biodegradable soft tissue fixation device designed for orthopedic applications. It functions as a fastener to secure soft tissues, such as tendons or ligaments, to bone or other tissues, providing stable fixation through a press-fit mechanism.

This device is supplied sterile and intended for single-use in surgical settings. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance, MDD, and MDR authorizations. The anchor is available in various sizes and configurations, as referenced in the associated product codes, and must be stored according to manufacturer instructions to maintain sterility and integrity.

Other devices from Linvatec Corporation d/b/a ConMed Linvatec

Questions

AI-generated answers, 18 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 tissues can the Genesys PressFT Suture Anchor be used to secure, and how does it achieve stability?

    The Genesys PressFT Suture Anchor is designed to secure soft tissues like tendons or ligaments to bone or other tissues. It provides stable fixation through a press-fit mechanism, which ensures a secure attachment without the need for additional sutures or anchors.

  • Is the Genesys PressFT Suture Anchor reusable, or is it intended for single-use only?

    The Genesys PressFT Suture Anchor is explicitly intended for single-use in surgical settings. This ensures sterility and safety for each patient, as reuse could compromise integrity and introduce infection risks.

  • How should the Genesys PressFT Suture Anchor be stored to maintain its sterility and functionality?

    The device must be stored according to the manufacturer’s instructions to preserve sterility and structural integrity. Since it is supplied sterile, proper storage conditions—such as sealed packaging and controlled environments—are critical to prevent contamination or damage before use.

  • What regulatory pathways has the Genesys PressFT Suture Anchor followed, and what does this mean for its use?

    The Genesys PressFT Suture Anchor has received FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) authorizations. This means it meets regulatory standards for safety and effectiveness in the markets where these approvals apply, ensuring compliance with applicable medical device laws.

  • Are there multiple sizes or configurations available for the Genesys PressFT Suture Anchor, and how might this affect my selection?

    Yes, the Genesys PressFT Suture Anchor is available in various sizes and configurations, as indicated by the associated product codes. This variety allows clinicians to choose the appropriate size for specific anatomical or procedural requirements, ensuring optimal fixation for different soft tissue applications.