# K073412: Gryphon BR and Healix BR Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Jan 17, 2008 after 44 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K971358 (1997). 24 ancestors in all.
44 later devices descend from it; 10 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071481: Healix Anchor, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 1.
- K070925: Modification to: Bioknotless BR Anchor / Lupine BR Anchor, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 1.
- K071177: Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew, Arthrex, Inc. (2007) Summary page 1.
- K032717: Biocryl Rapide Interference Screw, Mitek Worldwide (2004) Summary page 1.
- K060830: Milagro Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2006) Summary page 1.

## Most influential descendants
- K090124: Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814 (2009), 25 descendants of its own
- 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 (2010), 24 descendants of its own
- K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend (2011), 15 descendants of its own
- K112249: Healix Knotless (TM) Anchor (2011), 13 descendants of its own
- K130917: Healix Advance Knotless BR Anchor (2013), 9 descendants of its own

## Recalls of this device
- Feb 24, 2011 · Not classified · Z-2208-2011: Metal debris in the shaft component of the device

## Indications for use
Gryphon BR Anchor is indicated for use in the following: Shoulder: Rotor 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. Healix BR Anchor is indicated for use in the following: Shoulder: Rotor 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.

Source page: https://510kreport.com/device/K073412
Methodology: https://510kreport.com/methodology