# K232683: Knotilus+ PEEK Knotless Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Oct 24, 2023 after 53 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 K961555 (1996). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 5.
- K151092: Arthrex Short Suture Anchors, Arthrex, Inc. (2016) Summary page 5.

## Most influential descendants
- K261363: Y-Knotless™ Flex Anchors (2026), 0 descendants of its own
- K250544: Knotilus+ Biocomposite Knotless Anchor (2025), 0 descendants of its own

## Indications for use
The Knotilus+ PEEK Knotless Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures: 2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift, or Capsulolabral Reconstruction Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament and Tendon Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand and /Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Hip: Acetabular Labral Repair 2.4x8.9mm: Hip: Acetabular Labral Repair

Source page: https://510kreport.com/device/K232683
Methodology: https://510kreport.com/methodology