Skip to content

Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm

by Linvatec Corporation d/b/a ConMed Linvatec

510(k) K131035

Active European Union and United States

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) K131035↗

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 NumberK131035 Date2 Jul 2013ClearedStatusActive
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  • Withdrawn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/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 Y-Knot Flex All-Suture Anchor is a surgical device designed for orthopedic applications, specifically for securing soft tissue to bone. It features a flexible, knotless anchor system that incorporates two #2 (5 metric) Hi-Fi sutures, enabling stable fixation without the need for manual knot tying.

This device is supplied sterile and intended for single-use in orthopedic procedures. The 1.8 mm anchor is compatible with MRI environments and is regulated under FDA 510(k) clearance (K131035) and the Medical Devices Directive (MDD). Storage and handling follow standard surgical instrument protocols to maintain sterility and functionality.

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 is the primary use of the Y-KNOT FLEX ALL-SUTURE ANCHOR in orthopedic surgery?

    The Y-KNOT FLEX ALL-SUTURE ANCHOR is specifically designed to secure soft tissue to bone during orthopedic procedures. Its flexible, knotless anchor system eliminates the need for manual knot tying, providing stable fixation with two included #2 (5 metric) Hi-Fi sutures.

  • Is this device compatible with MRI environments, and why might that matter?

    Yes, the Y-KNOT FLEX ALL-SUTURE ANCHOR is explicitly designed to be MRI-compatible, which is important for patients who may require postoperative imaging. This ensures the device won’t interfere with MRI scans, reducing the risk of complications or misdiagnosis due to imaging artifacts.

  • How is the Y-KNOT FLEX ALL-SUTURE ANCHOR supplied, and what does that mean for its use?

    The device is supplied sterile and intended for single-use only, meaning it is pre-packaged in a sterile condition and should not be reused after a single surgical procedure. This ensures patient safety and maintains the integrity of the fixation system.

  • What storage and handling precautions should be taken to keep the device functional?

    Since the device is sterile and single-use, it must be stored and handled according to standard surgical instrument protocols to preserve sterility and functionality. This includes keeping it in its original packaging until immediately before use, avoiding contamination, and adhering to facility-specific sterile processing guidelines.

  • What regulatory pathways does this device follow, and what does that mean for its use?

    The Y-KNOT FLEX ALL-SUTURE ANCHOR is regulated under FDA 510(k) clearance (K131035) and the Medical Devices Directive (MDD). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets EU safety and performance standards, ensuring its compliance with both U.S. and European medical device regulations.