# K180759: SECULOK™ Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Aug 9, 2018 after 140 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: 10 generations back to K911837 (1991). 136 ancestors in all.
No later device cites it as a predicate yet.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070758: Stryker Peek Zip Suture Anchor, Stryker Endoscopy (2007) Summary page 4.
- K101100: Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503, Conmed Linvatec (2010) Summary page 4.
- K120824: 3.9MM Reelx STT Suture Anchor System, Stryker Corp. (2012) Summary page 4.
- K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 4.

## Indications for use
SECULOK™ Suture Anchor is for fixation or reattachment of soft tissue including ligament and tendon to bone especially with below indications. - Shoulder: Bankart repair, SLAP lesion repair, Acromio-Clavicular separation repair, Rotator Cuff repair, Capsular shift or Capsulolabral reconstruction, Biceps tenodesis, Deltoid repair. - Foot/Ankle: Medial or lateral stabilization, Achilles tendon repair. - Elbow/Wrist/Hand: Ulnar or Radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment. - Knee: Extra-capsular repairs: Medial/lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis Patellar realignment and tendon repairs : Vastus medialis obliquous advancement

Source page: https://510kreport.com/device/K180759
Methodology: https://510kreport.com/methodology