510(k) · Cleared
Recalled · 2007Axya Model 6500 Axyaloop Self-Tapping Bone Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axya Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 7, 2005 as substantially equivalent to K011912 (Axya Medical, Inc., 2001) and 1 other predicate after a 25-day review. Its family tree reaches back 2 generations to 1998. 9 later devices descend from it. It has been recalled 21 times.
- Decided
- Oct 7, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 21
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983818 (1998). 3 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK983818 Mitek Fastin RC AnchorMitek Products · 1998
- 1 generation backK011912 Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000Axya Medical, Inc. · 2001
- This deviceK052491 Axya Model 6500 Axyaloop Self-Tapping Bone AnchorAxya Medical, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK083268 Tornier, Inc., Insite Suture AnchorsTornier, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK110773 Tornier Insite FT Suture AnchorTornier, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK150715 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
- Descendant · 4 generations on · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc. · 2009 · cites it directly7descendants
- K110773Tornier Insite FT Suture AnchorTornier, Inc. · 2011 · 2 generations on5descendants
- K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015 · 3 generations on2descendants
- K201636Hercules Suture Anchor SystemIn2bones USA, LLC · 2020 · 3 generations on1descendant
- K253538TeKBrace Knotless AnchorTheramicro · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983818 | Mitek Fastin RC Anchor | Mitek Products | 1998 | — |
| −1 | K011912 | Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000 | Axya Medical, Inc. | 2001 | — |
| 0 (this device) | K052491 | Axya Model 6500 Axyaloop Self-Tapping Bone Anchor | Axya Medical, Inc. | 2005 | — |
| +1 | K083268 | Tornier, Inc., Insite Suture Anchors | Tornier, Inc. | 2009 | — |
| +2 | K110773 | Tornier Insite FT Suture Anchor | Tornier, Inc. | 2011 | — |
| +3 | K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | Tornier, Inc. | 2015 | — |
| +3 | K201636 | Hercules Suture Anchor System | In2bones USA, LLC | 2020 | — |
| +4 | K253538 | TeKBrace Knotless Anchor | Theramicro | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011912 | Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000Summary page 1…Product code: MBI and HWC - Class II Predicate Devices Axya Model 2000 AxyaLoop TM Self-Tapping Bone Anchor [51 0(k) Number K01 1912] Arthrex Inc. CorkscreWTM Suture Anchor Model AR-i 925S [501 (k) Number K003816] Descrip… | 2001 |
| * | K003816 | Arthrex Titanium Corkscrew, 3.5 MM, Arthrex Titanium Corkscrew, 5.0 MM, Arthrex Titanium…Summary page 1…Bone Anchor [51 0(k) Number K01 1912] Arthrex Inc. CorkscreWTM Suture Anchor Model AR-i 925S [501 (k) Number K003816] Description The device is designed with a corkscrew style thread 6.5 mm in diameter, for use in a range of soft tissue to bone… | 2001 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2007 | Not classified | Z-0335-2008 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | 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 | Package design/selection | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging |
The 5 latest of 21 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083268 (Tornier, Inc., 2009) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K011912.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052491 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052491: Axya Model 6500 Axyaloop Self-Tapping Bone Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052491
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026