# K223889: Stativ® Knotted UHMWPE Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Healthium Medtech Limited
- Decided: Mar 22, 2023 after 85 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). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203268: Arthrex FiberTak Suture Anchor, Arthrex, Inc. (2020) Summary page 5.
- K192709: Fixone All Suture Anchor, Aju Pharm Co., Ltd. (2020) Summary page 5.

## Indications for use
The STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures: 1. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. 2. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction. 3. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure. 4. Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty). 5. Elbow: Biceps tendon reattachment, Ulnar or Radial collateral ligament reconstruction. 6. Hip: Acetabular labral repair, Capsular repair, Gluteal Tendon Repair.

Source page: https://510kreport.com/device/K223889
Methodology: https://510kreport.com/methodology