# K250095: All-Suture Dual Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Suturetech, Inc.
- Decided: Sep 5, 2025 after 234 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: 6 generations back to K961555 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120509: Stryker All Suture Anchors, Stryker (2012) Summary page 5.

## Indications for use
The SutureTech All-Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: Shoulder: Rotator Cuff Repair, Ban kart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio- Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair. FooUAnkle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-Foot Reconstruction, Metatarsal Ligament Repair, Digital Tendon Transfers. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexer and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Repairs. Elbow : Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair.

Source page: https://510kreport.com/device/K250095
Methodology: https://510kreport.com/methodology