# K050358: Artherx Corkscrew FT II Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Apr 15, 2005 after 60 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: 1 generation back to K971723 (1997). 2 ancestors in all.
40 later devices descend from it; 5 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003816: Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM, Arthrex Titanium Corkscrew 6.5MM, Arthrex, Inc. (2001) Summary page 1.
- K971723: Fastak Suture Anchor (11.7MM)/(7.5MM), Arthrex, Inc. (1997) Summary page 1.

## Most influential descendants
- K072063: KFX Tissue Fixation System and Accessories (2007), 18 descendants of its own
- K081598: Suture Lock Nail Bone Anchor with White (KFX-W-200) & Blue (KFX-B-200) Fiberforce Suture (2008), 16 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
- K090075: Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258 (2009), 13 descendants of its own
- K091094: Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264 (2009), 7 descendants of its own

## Indications for use
The Arthrex Corkscrew FT Suture Anchor is intended for fixation of suture to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repairs, 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, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction. Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K050358
Methodology: https://510kreport.com/methodology