# K220464: Tigon Medical Gryphon Anchor Line

- Pathway: 510(k) (Traditional)
- Applicant: Tigon Medical
- Decided: Mar 22, 2023 after 398 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: 8 generations back to K961555 (1996). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182507: Tigon Medical Tissue Anchors, Tigon Medical (2019) 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 Gryphon Anchor Line is made up of four families of soft tissue fixation devices: Tomahawk Anchor, Dual Anchor, Eye-Deal Anchor, and Tenodesis Anchors. The entirety of the gryphon anchor line is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff repairs, Bicep tenodesis. Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair; Knee: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquus advancement), Iliotibial band tenodesis; Foot and Ankle: Hallux valgus repairs, Medial or Lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy In addition to these indications, the Tenodesis Anchors, a sub family of the gryphon anchor line will also be indicated for: Foot and Ankle: Flexor hallucis longus for Achilles tendon reconstructions, tendon transfers in the foot and Ankle Knee: ACL Repair Hand/Wrist: Carpometacarpal joint arthroplasty, carpal ligament reconstructions and repairs, tendon transfer in hand/wrist

Source page: https://510kreport.com/device/K220464
Methodology: https://510kreport.com/methodology