# K003816: Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM, Arthrex Titanium Corkscrew 6.5MM

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 9, 2001 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
No predicates in its family tree.
66 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ANCHORLOK Soft Tissue Anchor System: named in the summary without a submission number
- (no number) Mitek Knotless Anchor: named in the summary without a submission number
- (no number) Straight-in Orthopedic fixation system: named in the summary without a submission number
- (no number) KSEA Flipptack: named in the summary without a submission number
- (no number) Acumed Suture Anchor: named in the summary without a submission number

## Most influential descendants
- K050358: Artherx Corkscrew FT II Suture Anchor (2005), 40 descendants of its own
- K060664: Fastin RC Anchor (2006), 30 descendants of its own
- K082282: Healix TI Anchor (2008), 21 descendants of its own
- 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

## Indications for use
The Titanium Corkscrew 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-ClavicularSeparation Repair, Deltold Repair, Capsular Shiftor CapsulolabralReconstruction FootlAnkle: Lateral Stabilization,Medial Stabilization,Achilles Tendon Repair, Hallux Valgus Reconstruction,Midfoot Reconstruction,Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, PatellarTendon Repair, PosteriorOblique LigamentRepair, and lliotibialBand Tenodesis HandlWrist: ScapholunateLigament Reconstruction,Ulnar Collateral Ligament Reconstruction,Radial CollateralLigamentReconstruction Elbow. Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial CollateralLigamentReconstruction Pelvis: Bladder Neck Suspension for female urinary incontinencedue to urethralhyper mobilityor intrinsicsphincterdeficiency

Source page: https://510kreport.com/device/K003816
Methodology: https://510kreport.com/methodology