# K011912: Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000

- Pathway: 510(k) (Traditional)
- Applicant: Axya Medical, Inc.
- Decided: Aug 31, 2001 after 73 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: 1 generation back to K983818 (1998). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983818: Mitek Fastin RC Anchor, Mitek Products (1998) Summary page 2.

## Most influential descendants
- K052491: Axya Model 6500 Axyaloop Self-Tapping Bone Anchor (2005), 9 descendants of its own
- K083268: Tornier, Inc., Insite Suture Anchors (2009), 7 descendants of its own
- K110773: Tornier Insite FT Suture Anchor (2011), 5 descendants of its own
- K150715: 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors (2015), 2 descendants of its own
- K201636: Hercules Suture Anchor System (2020), 1 descendant of its own

## Indications for use
The Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic monofilament non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 5mm anchor may typically be used to repair rotator cuff injuries. The 3 mm anchor may typically be used to repair recurrent dislocation of the shoulder where the anchor is placed through the metaphyseal cortex such as in the case of a Bankart lesion repair procedure.

Source page: https://510kreport.com/device/K011912
Methodology: https://510kreport.com/methodology