# K243790: GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek
- Decided: Feb 5, 2025 after 57 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: 10 generations back to K971358 (1997). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073412: Gryphon BR and Healix BR Anchors, Depuy Mitek, A Johnson & Johnson Company (2008) Summary page 6.
- K090124: Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814, Depuy Mitek, A Johnson & Johnson Company (2009) Summary page 6.
- K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend, Depuy Mitek, A Johnson & Johnson Company (2011) Summary page 6.

## Indications for use
The GRYPHON X Anchor is intended for: - Shoulder: Biceps Tenodesis; - Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; - Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis, Medial Patellofemoral Ligament Reconstruction; - Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction The HEALIX TRANSTEND Anchor is intended for: - Shoulder: Rotator Cuff, Partial Thickness Rotator Cuff, Biceps Tenodesis, Acromio-Clavicular Separation, Deltoid Repair; - Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-Foot Reconstruction, Hallux Valgus Repair, Metatarsal Ligament/Tendon Repairs; - Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; - Elbow: Lateral Epicondylitis Repair; - Wrist: Scapholunate Ligament Reconstruction; - Hip: Capsular Repair, Acetabular Labral Repair

Source page: https://510kreport.com/device/K243790
Methodology: https://510kreport.com/methodology