# K162429: ZipE Knotless Tissue Repair and Attachment Devices

- Pathway: 510(k) (Traditional)
- Applicant: Ziptek, LLC
- Decided: Mar 13, 2017 after 195 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961555 (1996). 17 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974847: 5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM Parachute Corkscrew Suture Anchor Model AR-22235, Arthrex, Inc. (1998) Summary page 4.
- K071704: Sleeve and Button Soft Tissue Devices, Biomet Sports Medicine, Inc. (2007) Summary page 4.
- K071177: Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew, Arthrex, Inc. (2007) Summary page 4.

## Most influential descendants
- 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
- K211322: Paratrooper Plantar Plate Repair System (2021), 0 descendants of its own

## Indications for use
The ZIPE® Knotless Tissue Repair and Attachment Devices are intended for fixation of tissue to bone and tissue to tissue. 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 Repair Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Source page: https://510kreport.com/device/K162429
Methodology: https://510kreport.com/methodology