# K974847: 5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM Parachute Corkscrew Suture Anchor Model AR-22235

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 6, 1998 after 220 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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) Arthrex FASTak: named in the summary without a submission number
- (no number) Linvatec Bio-Anchor: named in the summary without a submission number

## Most influential descendants
- K162429: ZipE Knotless Tissue Repair and Attachment Devices (2017), 5 descendants of its own
- K200028: Coronet Soft Tissue Fixation System (2020), 2 descendants of its own
- K220966: Sinefix (2023), 1 descendant of its own
- K191227: Paratrooper Plantar Plate Repair System (2020), 1 descendant of its own
- K254176: Sinefix (2026), 0 descendants of its own

## Indications for use
The Parachute Corkscrew Suture Anchor is intended for fixation of tissue 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 Cap§ulolabral 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, 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 Ligamant Reconstruction

Source page: https://510kreport.com/device/K974847
Methodology: https://510kreport.com/methodology
