Skip to content

GRYPHON Anchors with DYNACORD Suture

by Medos International SARL

510(k) K181809

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK181809 Date3 Aug 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 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.

This device is a biodegradable soft tissue fastener used for fixation in orthopedic applications. It consists of a Gryphon anchor combined with Dynacord suture material.

It is supplied as a sterile, single-use device and has received FDA 510(k) clearance (K181809) for marketing. The device is intended for use in surgical settings where soft tissue to bone fixation is required.

Other devices from Medos International SARL

See all devices from Medos International SARL →

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 GRYPHON® Anchors with DYNACORD Suture used for?

    This device is a biodegradable soft tissue fastener used for fixation in orthopedic applications where soft tissue to bone attachment is required. It combines a Gryphon anchor with Dynacord suture material to provide secure, temporary fixation that gradually absorbs as tissue heals, eliminating the need for removal surgery.

  • How is the GRYPHON® Anchors with DYNACORD Suture supplied and is it reusable?

    The device is supplied as a sterile, single-use unit. It is intended for one-time use only during surgical procedures and must not be reprocessed or reused, as doing so could compromise sterility, structural integrity, and patient safety due to its biodegradable design and lack of validation for reuse.

  • What regulatory clearance does the GRYPHON® Anchors with DYNACORD Suture have?

    The device has received FDA 510(k) clearance under submission number K181809, which was granted on August 3, 2018. This clearance confirms the device is substantially equivalent to a legally marketed predicate device for its intended use in soft tissue to bone fixation in orthopedic surgery.