# K260921: Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

- Pathway: 510(k) (Special)
- Applicant: Tigon Medical
- Decided: Apr 21, 2026 after 33 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: 11 generations back to K961555 (1996). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252596: Tigon Medical Knotless and Dual Javelin All-Suture Anchors, Tigon Medical (2025) Summary page 5.
- K242529: Tigon Medical All-Suture Anchors (ASA), Tigon Medical (2024) Summary page 5.
- K220464: Tigon Medical Gryphon Anchor Line, Tigon Medical (2023) Summary page 5.
- K182507: Tigon Medical Tissue Anchors, Tigon Medical (2019) Summary page 5.

## Indications for use
The Tigon Medical 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 ofFlexor 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/K260921
Methodology: https://510kreport.com/methodology