# K022207: Axya Model 3000 Axyaloop Titanium Bone Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Axya Medical, Inc.
- Decided: Oct 4, 2002 after 88 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K039711: Axya Medical, Inc. Model 1000 AxyaLoop Suture Anchor. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K007971: Orthopaedic Biosystems Mini Tac 2.0 mm Bone Anchor. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K070773: Axya, Model 3000  Axyzloop Titanium Bone Anchor (2007), 0 descendants of its own

## Indications for use
The Axya Model 3000 AxyaLoop Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture in repairs of the extremities such as those shown below: Foot and Ankle 1 Hallux Valgus repairs 2 Medial or lateral instability repairs/reconstructions 3 Achilles tendon repairs/reconstructions 4 Midfoot reconstructions 5 Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist and Hand 1 Scapholunate ligament reconstructions 2 Ulnar and radial collateral ligament reconstructions 3 Lateral epicondylitis repair 4 Biceps tendon reattachment

Source page: https://510kreport.com/device/K022207
Methodology: https://510kreport.com/methodology