# K043337: Arthrex Bio-Corkscrew FT Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Dec 14, 2004 after 11 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 K990987 (2000). 2 ancestors in all.
145 later devices descend from it; 4 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003227: Bio-Absorbable Corkscrew Model AR-1920B, Arthrex, Inc. (2001) Summary page 1.
- K990987: Bio-Absorbable Corkscrew, Model AR-1920B, Arthrex, Inc. (2000) Summary page 1.

## Most influential descendants
- K061665: Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT (2006), 114 descendants of its own
- K112111: Acu-Sinch Repair System and Acumed Suture Anchor (2011), 49 descendants of its own
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), 40 descendants of its own
- K070882: Stryker Peek Twinloop Tac (2007), 35 descendants of its own
- K120509: Stryker All Suture Anchors (2012), 27 descendants of its own

## Indications for use
The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures: 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: Anterior Cruciate Ligament Repair, 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, Ulnar or Radial Collateral Ligament Reconstruction. Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K043337
Methodology: https://510kreport.com/methodology