# K100012: Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS Anchor W/Orthocord, Gryphon P BR a

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Apr 30, 2010 after 116 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: 8 generations back to K971358 (1997). 26 ancestors in all.
24 later devices descend from it; 8 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 1.
- K073412: Gryphon BR and Healix BR Anchors, Depuy Mitek, A Johnson & Johnson Company (2008) Summary page 1.

## Most influential descendants
- K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend (2011), 15 descendants of its own
- K120078: Healix Advance BR Anchor (2012), 9 descendants of its own
- K133794: 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix Advance BR Anchor, with 2 or 3 (2014), 8 descendants of its own
- K211002: Grappler Suture Anchor System (2021), 6 descendants of its own
- K103712: Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord (2011), 6 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K100012
Methodology: https://510kreport.com/methodology