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PopLok Suture Anchors 2.8 mm/3.3 mm

by Conmed Corporation

510(k) K181120

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) K181120↗

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 NumberK181120 Date21 Dec 2018ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR 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  • Withdrawn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/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
2.8 mm/3.3 mm PopLok Suture Anchors
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 PopLok Suture Anchors 2.8 mm/3.3 mm are bioabsorbable, self-locking anchors designed for soft tissue fixation in orthopedic procedures. These anchors provide secure attachment of tendons, ligaments, or other soft tissues to bone, facilitating repair and stabilization in joint reconstruction or tendon reattachment surgeries.

Supplied sterile in a single-use package, these anchors are intended for use in orthopedic settings under sterile conditions. They are available in two sizes, 2.8 mm and 3.3 mm, and are regulated under FDA 510(k) clearance (K181120), MDD, and MDR. The anchors are classified under product code MBI and are distributed by Conmed Corporation.

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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 are these suture anchors designed for, and how do they work?

    The 2.8 mm/3.3 mm PopLok Suture Anchors are specifically designed for soft tissue fixation in orthopedic surgeries, such as joint reconstruction or tendon reattachment. They provide secure attachment of tendons, ligaments, or other soft tissues to bone by anchoring them in place. Their self-locking mechanism ensures stability during the healing process, helping to facilitate repair and stabilization in procedures like rotator cuff repairs or ACL reconstructions.

  • Are these suture anchors reusable, and if not, how should they be handled to maintain sterility?

    No, these PopLok Suture Anchors are intended for single-use only and are supplied sterile in a sealed package. To maintain sterility, the package should remain unopened until immediately before use, and the anchors should be handled using sterile techniques in a controlled, sterile environment, such as an operating room or sterile tray setup.

  • What sizes are available, and how might a clinician choose between the 2.8 mm and 3.3 mm options?

    The PopLok Suture Anchors come in two sizes: 2.8 mm and 3.3 mm. The choice between them depends on the specific surgical requirements, such as the size of the tendon or ligament being reattached and the bone tunnel diameter. Generally, the 2.8 mm is used for smaller or thinner tissues, while the 3.3 mm is better suited for larger or thicker tissues requiring greater fixation strength.

  • How should these anchors be stored before use, and what are the key details about their packaging?

    These anchors are supplied in a sterile, single-use package designed for surgical settings. Storage should follow the manufacturer’s instructions, typically in a clean, dry place away from direct sunlight or extreme temperatures. The package should remain intact until the moment of use to preserve sterility, and any unused anchors should not be reused or restocked.

  • What regulatory pathways have these suture anchors gone through, and how does that affect their use in clinical settings?

    The PopLok Suture Anchors have undergone FDA 510(k) clearance (K181120) under a special review process, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in the EU. This means they meet U.S. and European regulatory standards for safety and effectiveness in their intended orthopedic applications, ensuring they can be legally used in clinical settings where these approvals apply.