# K173269: KATOR Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Kator, LLC
- Decided: May 30, 2018 after 230 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: 7 generations back to K961555 (1996). 22 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 5.
- K093897: Smith & Nephew Footprint Ultra PK Suture Anchor, Smith & Nephew Inc., Endoscopy Div. (2010) Summary page 5.
- K113274: Footprint Ultra PK Suture Anchor, Smith & Nephew, Inc. (2012) Summary page 5.
- K123579: Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SL, Smith & Nephew, Inc. (2013) Summary page 5.
- K162386: KATOR Suture Anchor, Kator, LLC (2016) Summary page 5.

## Most influential descendants
- K242477: Shoulder Soft Tissue Anchors (2025), 0 descendants of its own
- K182736: OIC Suture Anchor System (2018), 0 descendants of its own

## Indications for use
The KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: Shoulder: Rotator Cuff Repairs, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. 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 or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Hip: Capsular Repair, Acetabular Labral Repair.

Source page: https://510kreport.com/device/K173269
Methodology: https://510kreport.com/methodology
