Skip to content

AxyaLoop Nonabsorbable Bone Anchor

by Axya Medical, Inc. 510(k)

Active United States

510(k) K060970

Overview

The AxyaLoop Nonabsorbable Bone Anchor is a surgical device classified as a bone anchor (product code JDR) under FDA nomenclature. It is designed to provide secure fixation between soft tissue and bone, facilitating procedures such as rotator cuff repair. Constructed from a nonabsorbable acetal polymer, the device offers durable attachment without degradation over time. Its design ensures minimal tissue reaction while maintaining structural integrity during use.

This device is supplied as a sterile, single-use implant intended for orthopedic applications. It is available in multiple sizes, including those referenced in prior clearances (3mm, 5mm, and 6.5mm), though exact dimensions must be verified against the manufacturer’s specifications. The AxyaLoop Nonabsorbable Bone Anchor is regulated under FDA 510(k) clearance (K060970) as substantially equivalent to previously cleared bone anchors. Storage and handling must comply with sterile medical device protocols to preserve integrity prior to surgical use.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060970 Date5 Jul 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

21 recalls · FDA

  • 21 recalls, same reason

    • Terminated Z-0355-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0337-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0334-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0333-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0344-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0332-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0348-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0354-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0350-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0346-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0343-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0352-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0335-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0339-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0351-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0341-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0349-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0353-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0342-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0347-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)
    • Terminated Z-0331-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K060970, on the same 510(k)

    Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
JDR
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Axya Medical, Inc.

See all devices from Axya Medical, Inc. →

Questions

  • What is the AxyaLoop Nonabsorbable Bone Anchor used for?

    The AxyaLoop Nonabsorbable Bone Anchor is designed to provide secure fixation between soft tissue and bone, commonly used in procedures like rotator cuff repair. Its durable acetal polymer construction ensures long-term stability without degradation, reducing the risk of loosening or failure during healing.

  • How is the AxyaLoop Nonabsorbable Bone Anchor supplied and what are its sizes?

    The device is supplied sterile and intended for single-use only. It comes in multiple sizes, including 3mm, 5mm, and 6.5mm, though exact dimensions should always be confirmed against the manufacturer’s official specifications to ensure compatibility with the surgical application.

  • Is the AxyaLoop Nonabsorbable Bone Anchor reusable or single-use?

    This device is explicitly intended for single-use only. Its nonabsorbable acetal polymer material is not designed for sterilization or reuse, and repeated use could compromise structural integrity or sterility, posing risks to the patient.

  • What materials is the AxyaLoop Nonabsorbable Bone Anchor made from?

    The AxyaLoop Nonabsorbable Bone Anchor is constructed from a nonabsorbable acetal polymer. This material choice ensures durability and resistance to degradation over time, minimizing tissue reaction while maintaining stability during surgical procedures.

  • How should the AxyaLoop Nonabsorbable Bone Anchor be stored?

    The device must be stored and handled according to sterile medical device protocols to preserve its integrity before use. Improper storage—such as exposure to moisture, extreme temperatures, or contamination—could compromise sterility or physical properties, making it unsafe for surgical implantation.