# K233258: Shadow Knotless All-Suture Anchors

- Pathway: 510(k) (Special)
- Applicant: Responsive Arthroscopy, LLC
- Decided: Oct 23, 2023 after 25 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: 13 generations back to K911837 (1991). 115 ancestors in all.
No later device cites it as a predicate yet.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230094: Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors, Responsive Arthroscopy, LLC (2023) Summary page 5.
- K190446: Responsive Arthroscopy Wedge Push-In Suture Anchors, Responsive Arthroscopy, LLC (2019) Summary page 5.
- K181076: Responsive Arthroscopy Wedge Push-In Suture Anchors, Responsive Arthroscopy, LLC (2019) Summary page 5.

## Indications for use
The Shadow Knotless 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, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair. Foot/Ankle: 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, Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Carpal Ligament Reconstruction, Repair of Flexor 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/K233258
Methodology: https://510kreport.com/methodology