# K052491: Axya Model 6500 Axyaloop Self-Tapping Bone Anchor

- Pathway: 510(k) (Special)
- Applicant: Axya Medical, Inc.
- Decided: Oct 7, 2005 after 25 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983818 (1998). 3 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011912: Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000, Axya Medical, Inc. (2001) Summary page 1.
- K003816: Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM, Arthrex Titanium Corkscrew 6.5MM, Arthrex, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K253538: TeKBrace Knotless Anchor (2026), 0 descendants of its own

## Recalls of this device
- Sep 27, 2007 · Not classified · Z-0335-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0341-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0343-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0349-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0355-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0339-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0342-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0350-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0337-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0348-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0351-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0353-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0331-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0332-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0333-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0334-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0344-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0346-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0347-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0352-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- Sep 27, 2007 · Not classified · Z-0354-2008: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging

## Indications for use
The Axya Model 6500 AxyaLoop TM Self-Tapping Bone Anchor is indicated for securing synthetic non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 6.5 mm and 5 mm anchors 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/K052491
Methodology: https://510kreport.com/methodology