# K082282: Healix TI Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Co.
- Decided: Nov 7, 2008 after 88 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010673 (2001). 16 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 38 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.
- K060664: Fastin RC Anchor, Depuy Mitek (2006) Summary page 1.
- K041075: Fastin RC Anchor, Depuy Mitek, A Johnson & Johnson Company (2004) Summary page 1.
- K052631: Super Quickanchor Plus (with Orthocord Suture), Depuy Mitek, A Johnson & Johnson Company (2005) Summary page 1.
- K040004: Orthocord Suture, Depuy Mitek (2004) Summary page 1.
- K043298: Blue Orthocord Suture, Depuy Mitek (2004) 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
- 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
- K222091: Grappler Suture Anchor System (2022), 3 descendants of its own
- K223589: Grappler Suture Anchor R3FLEX IOL System (2023), 2 descendants of its own

## Indications for use
Healix 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, Patella tendon repair and secondary fixation in ACL / PCL reconstruction Elbow: Biceps Tendon Reattachment, Uinar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

Source page: https://510kreport.com/device/K082282
Methodology: https://510kreport.com/methodology