# K252596: Tigon Medical Knotless and Dual Javelin All-Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Tigon Medical
- Decided: Dec 4, 2025 after 111 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 K961555 (1996). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242529: Tigon Medical All-Suture Anchors (ASA), Tigon Medical (2024) Summary page 4.
- K130458: Knotless Fibertak Suture Anchor, Arthrex, Inc. (2013) Summary page 5.

## Most influential descendants
- K260921: Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line (2026), 0 descendants of its own

## Indications for use
The Tigon Medical Knotless and Dual Javelin All-Suture Anchors are an extension to the Tigon Medical All-Suture Anchor line cleared in K242529 (December 20, 2024). The Tigon Medical Javelin All-Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: • Elbow: Biceps Tendon Reattachment. Ulnar or Radial Collateral Ligament Reconstruction • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair • Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal 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 Repair • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction • Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis • Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

Source page: https://510kreport.com/device/K252596
Methodology: https://510kreport.com/methodology