# K250544: Knotilus+ Biocomposite Knotless Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: May 23, 2025 after 87 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K961555 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232683: Knotilus+ PEEK Knotless Anchor, Stryker Endoscopy (2023). Our reading of the summary gave K232863, FDA’s number for Radiant Renewal Skincare Wand (HD-15, HD-15A) (Shenzhen Kaiyan Medical Equipment Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Knotilus+ PEEK Knotless Anchor”.
- K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 5.
- K151092: Arthrex Short Suture Anchors, Arthrex, Inc. (2016) Summary page 5.
- K201786: Arthrex Mini Hip PushLock, Arthrex, Inc. (2020) Summary page 5.

## Indications for use
The Knotilus+ Biocomposite 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/K250544
Methodology: https://510kreport.com/methodology