# K182507: Tigon Medical Tissue Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Tigon Medical
- Decided: Jan 21, 2019 after 131 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: 7 generations back to K961555 (1996). 20 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K121018: Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an, Smith & Nephew, Inc. (2012) Summary page 4.
- K122314: Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only, Cayenne Medical, Inc. (2012) Summary page 4.

## Most influential descendants
- K220464: Tigon Medical Gryphon Anchor Line (2023), 1 descendant of its own
- 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 Tissue Anchor System 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), Acromnioclavicular separation repairs, Deltoid repairs, Rotator cuff repairs, Bicep tenodesis; Elbow, Wrist, and Hand: Biceps tendon reattachmnent, 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 medials obliquous advancement), Illiotibial 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

Source page: https://510kreport.com/device/K182507
Methodology: https://510kreport.com/methodology