# K971723: Fastak Suture Anchor (11.7MM)/(7.5MM)

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 30, 1997 after 82 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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.
274 later devices descend from it; 7 cite it directly.
0 of 275 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) Mitek GII: named in the summary without a submission number
- (no number) Statak 3.5: named in the summary without a submission number
- (no number) Questus 3.5: named in the summary without a submission number
- (no number) Mainstay 3.5: named in the summary without a submission number
- (no number) PeBA C: named in the summary without a submission number
- (no number) Statak 2.5: named in the summary without a submission number
- (no number) Questus 2.5: named in the summary without a submission number
- (no number) Mainstay 2.7: named in the summary without a submission number

## Most influential descendants
- K051219: Pushlock (2005), 151 descendants of its own
- K990361: Headed Bio-Absorbable Corkscrew Model #AR-1921BU (1999), 79 descendants of its own
- K020056: Duet Suture Anchor (2002), 78 descendants of its own
- K030388: Impact Suture Anchor. Model 433510 (2003), 77 descendants of its own
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (2004), 76 descendants of its own

## Indications for use
The FASTak Suture Anchor (11.7mm) is intended for fixation of suture to bone. This product is intended for the following indications: Shoulder: Rotator 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, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament chalr Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reatrachment, Tenmus Eloow Repair, Ulnar or Radial Collateral Ligamant Reconstruction Pelvis: Bladder Neck Suspension for female urinary mcontmcnce due to urethral hyper mobility or intrinsic sphincter deficiency The FASTak Suture Anchor (7.5mm) is intended for fixation of suture to bone. This product is intended for the following indications: Shoulder: 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 Lxgament Repair, Patellar Tendon Repair, Posterior Oblique Ligament chalr Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reatrachment, Tenmus Eloow Repair, Ulnar or Radial Collateral Ligamant Reconstruction Peivis: Rladder Neck Suspension for female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency

Source page: https://510kreport.com/device/K971723
Methodology: https://510kreport.com/methodology