510(k) · Cleared
Recalled · 2007Model 3000 Axyaloop Bio-Absorbable Bone Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axya Medical, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Aug 5, 2005 as substantially equivalent to K041698 (Axya Medical, Inc., 2004) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 2001. 11 later devices descend from it. It has been recalled 21 times.
- Decided
- Aug 5, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- MAI
- Recalls
- 21
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003227 (2001). 4 ancestors in all, the oldest K000506 (2000). 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK003227 Bio-Absorbable Corkscrew Model AR-1920BArthrex, Inc. · 2001
- 1 generation backK041698 Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2004
- This deviceK051983 Model 3000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK060970 Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc. · 2006 · Recalled
- 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc. · 2006 · cites it directly10descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003227 | Bio-Absorbable Corkscrew Model AR-1920B | Arthrex, Inc. | 2001 | — |
| −1 | K041698 | Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor | Axya Medical, Inc. | 2004 | — |
| 0 (this device) | K051983 | Model 3000 Axyaloop Bio-Absorbable Bone Anchor | Axya Medical, Inc. | 2005 | — |
| +1 | K060970 | Axyaloop Nonabsorbable Bone Anchor | Axya Medical, Inc. | 2006 | 21 |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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 |
|---|---|---|---|
| * | K041698 | Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorSummary page 1…Product code: MAI Class II Predicate Devices Axya Model 5000 AxyaLoop TM Bio-Absorbable Bone Anchor [510(k) Number K041698] Arthrex Inc. BioFASTak TM Suture Anchor… | 2004 |
| * | K000506 | Bio-Fastak Suture Anchor, Model AR-1324BSummary page 1…98] Arthrex Inc. BioFASTak TM Suture Anchor Model AR-1324B [501(k) Number K000506] Description The device is designed with a corkscrew style thread 3.0 mm in diameter, for use in a range of soft tissue to… | 2000 |
What descends from it? (11)
See all 112 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 4 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K060970 (Axya Medical, Inc., 2006) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K041698.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Axya Model 3000 AxyaLoop Bio-Absorbable 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…
Read the full statement (120 words)
The Axya Model 3000 AxyaLoop Bio-Absorbable 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 and Lateral 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/K051983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051983: Model 3000 Axyaloop Bio-Absorbable Bone Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051983
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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