# K200028: Coronet Soft Tissue Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Conextions Medical
- Decided: Mar 4, 2020 after 58 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
Longest line of descent: 9 generations back to K904436 (1990). 75 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162429: ZipE Knotless Tissue Repair and Attachment Devices, Ziptek, LLC (2017) Summary page 4.
- K070882: Stryker Peek Twinloop Tac, Stryker Endoscopy (2007) Summary page 4.
- K013806: Synthes Metallic Spiked Washers, Synthes (Usa) (2002) Summary page 4.
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to, Biomet Manufacturing Corp (2013) Summary page 4.

## Most influential descendants
- K220966: Sinefix (2023), 1 descendant of its own
- K254176: Sinefix (2026), 0 descendants of its own

## Indications for use
Coronet Soft Tissue Fixation System is 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 Ligament Reconstruction  Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial Ligament Reconstruction

Source page: https://510kreport.com/device/K200028
Methodology: https://510kreport.com/methodology