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Paradigm All-Suture Anchor 1.8mm, White/Black #2

by Conmed Corporation

510(k) K190333

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) K190333↗

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 NumberK190333 Date18 Mar 2019ClearedStatusActive
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  • Withdrawn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
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
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 Paradigm All-Suture Anchor 1.8mm is a surgical fixation device designed for orthopedic applications. It is a self-tapping anchor intended to secure soft tissue or ligament grafts to bone, providing stable fixation for procedures such as rotator cuff repairs or anterior cruciate ligament reconstructions.

This device is supplied sterile and intended for single-use. It is classified under the product code MBI and is manufactured by Conmed Corporation. The 1.8mm anchor is available in a white/black color variant and is regulated under FDA 510K clearance (K190333) as well as the EU Medical Device Regulations (MDR) and Medical Device Directive (MDD). Storage and handling should comply with standard surgical instrument protocols.

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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 orthopedic procedures is the Paradigm All-Suture Anchor 1.8mm specifically designed to assist with?

    The Paradigm All-Suture Anchor 1.8mm is designed for securing soft tissue or ligament grafts to bone, making it suitable for procedures like rotator cuff repairs and anterior cruciate ligament (ACL) reconstructions. Its self-tapping mechanism ensures stable fixation, which is critical for these types of orthopedic surgeries.

  • Is the Paradigm All-Suture Anchor 1.8mm intended for reuse, or is it meant to be used only once?

    The Paradigm All-Suture Anchor 1.8mm is explicitly intended for single-use only. This is standard practice for surgical anchors to maintain sterility and reduce infection risks, ensuring patient safety during orthopedic procedures.

  • How should I store the Paradigm All-Suture Anchor 1.8mm to maintain its integrity before use?

    The device should be stored and handled according to standard surgical instrument protocols. Since it is supplied sterile, it’s important to keep it in a clean, dry environment, protected from contamination, until ready for use in the operating room.

  • What color variant is available for the 1.8mm Paradigm All-Suture Anchor, and does this affect its functionality?

    The 1.8mm Paradigm All-Suture Anchor is available in a white/black color variant (#2). The color does not impact its functionality—it is purely a visual identifier for the specific model and does not influence performance or compatibility.

  • What regulatory pathways does the Paradigm All-Suture Anchor 1.8mm follow, and how does this affect its availability?

    The device has been cleared under the FDA’s 510(k) pathway (K190333) as substantially equivalent to a predicate device, and it complies with the EU Medical Device Regulations (MDR) and the Medical Device Directive (MDD). This means it is legally available in the U.S. and EU markets for its intended orthopedic applications, provided it is used within its specified guidelines.