510(k) · Cleared
Recalled · 2007Axyaloop Nonabsorbable Bone Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axya Medical, Inc. · JDR Staple, Fixation, Bone
Cleared on Jul 5, 2006 as substantially equivalent to K051983 (Axya Medical, Inc., 2005) and 3 other predicates after an 89-day review. Its family tree reaches back 3 generations to 2001. 10 later devices descend from it. It has been recalled 21 times.
- Decided
- Jul 5, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- JDR
- Recalls
- 21
- Predicates
- 4
Its longest line of descent runs back 3 generations to K003227 (2001). 7 ancestors in all, the oldest K963402 (1996). 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK003227 Bio-Absorbable Corkscrew Model AR-1920BArthrex, Inc. · 2001
- 2 generations backK041698 Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2004
- 1 generation backK051250 Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2005
- This deviceK060970 Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc. · 2006
- 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 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · 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 |
|---|---|---|---|---|---|
| −3 | K003227 | Bio-Absorbable Corkscrew Model AR-1920B | Arthrex, Inc. | 2001 | — |
| −2 | K041698 | Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor | Axya Medical, Inc. | 2004 | — |
| −1 | K051250 | Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor | Axya Medical, Inc. | 2005 | — |
| 0 (this device) | K060970 | Axyaloop Nonabsorbable Bone Anchor | Axya Medical, Inc. | 2006 | — |
| +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 |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 |
| 2023 | 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K051983 | Model 3000 Axyaloop Bio-Absorbable Bone AnchorSummary page 1…Product code: MBI Class 1I Predicate Devices Axya Medical, Inc Bioabsorbable Bone Anchors - 3mm, 5mm and 6.5mm [501(k) Numbers K051983, K041698 and K051250] respectively Innovasive Devices Inc. Nanabsorbable 2.8mm and 3.5mm… | 2005 |
| * | K041698 | Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorSummary page 1…code: MBI Class 1I Predicate Devices Axya Medical, Inc Bioabsorbable Bone Anchors - 3mm, 5mm and 6.5mm [501(k) Numbers K051983, K041698 and K051250] respectively Innovasive Devices Inc. Nanabsorbable 2.8mm and 3.5mm ROC… | 2004 |
| * | K051250 | Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorSummary page 1…ass 1I Predicate Devices Axya Medical, Inc Bioabsorbable Bone Anchors - 3mm, 5mm and 6.5mm [501(k) Numbers K051983, K041698 and K051250] respectively Innovasive Devices Inc. Nanabsorbable 2.8mm and 3.5mm ROC… | 2005 |
| * | K963402 | Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone FastenerSummary page 1…0] respectively Innovasive Devices Inc. Nanabsorbable 2.8mm and 3.5mm ROC Suture Bone Fastener [501(k) Number K963402] Description The device described in this submission is designed with a corkscrew style thread and is available in 3.0mm, 5.0mm… | 1996 |
What descends from it? (10)
3 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 5 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K083268 (Tornier, Inc., 2009) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K051983.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (116 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060970 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060970: Axyaloop Nonabsorbable 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/K060970
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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