# K060970: Axyaloop Nonabsorbable Bone Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Axya Medical, Inc.
- Decided: Jul 5, 2006 after 89 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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: 3 generations back to K003227 (2001). 7 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051983: Model 3000 Axyaloop Bio-Absorbable Bone Anchor, Axya Medical, Inc. (2005) Summary page 1.
- K041698: Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor, Axya Medical, Inc. (2004) Summary page 1.
- K051250: Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor, Axya Medical, Inc. (2005) Summary page 1.
- K963402: Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener, Innovasive Devices, Inc. (1996) 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 AxyaLoopTM Nonabsorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications: Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial collateral andLateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

Source page: https://510kreport.com/device/K060970
Methodology: https://510kreport.com/methodology