# K181809: GRYPHON® Anchors with DYNACORD™ Suture

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: Aug 3, 2018 after 28 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K971358 (1997). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141259: Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek Anchor with Permacord, Gryphon Peek, Depuy Mitek, A Johnson & Johnson Company (2014) Summary page 4.

## Indications for use
The GRYPHON® BR Anchor with DYNACORD™ Suture is intended for: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular Repair, Acetabular Labral Repair The GRYPHON® PEEK Anchor with DYNACORD™ Suture is intended for: Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Elbow: Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular Repair, Acetabular Labral Repair

Source page: https://510kreport.com/device/K181809
Methodology: https://510kreport.com/methodology