510(k) · Cleared

Cleared

Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor

K041698510(k) TraditionalCleared Oct 5, 2004105-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Axya Medical, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Oct 5, 2004 as substantially equivalent to K003227 (Arthrex, Inc., 2001) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 2001. 14 later devices descend from it.

Decided: Oct 5, 2004
Review: 105 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K003227 (2001). 2 ancestors in all. 14 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK003227 Bio-Absorbable Corkscrew Model AR-1920BArthrex, Inc. · 2001
This deviceK041698 Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2004
Descendant · cites it directly · 11 of its ownK051983 Model 3000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2005 · Recalled
Descendant · cites it directly · 11 of its ownK051250 Axya, Model 6500 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

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2005high 2 (2005) · low 0 (2007)2026

Most influential descendants

Showing 5 of 14 · See all

K051983Model 3000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2005 · cites it directly11descendants
K051250Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2005 · cites it directly11descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003227	Bio-Absorbable Corkscrew Model AR-1920B	Arthrex, Inc.	2001	—
0 (this device)	K041698	Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor	Axya Medical, Inc.	2004	—
+1	K051983	Model 3000 Axyaloop Bio-Absorbable Bone Anchor	Axya Medical, Inc.	2005	21
+1	K051250	Axya, Model 6500 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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	2	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

FIG. 1 — Lineage of K041698, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K003227	Bio-Absorbable Corkscrew Model AR-1920B Summary page 1 …oduct code: MAI Class II Predicate Devices Arthrex Inc. 61o-Absorbable Corkscrew Suture Anchor Model AR-i 9208 [501 (k) Number K003227] Mitek Worldwide Biofastin RC Threaded Suture Anchor [510(k) Number K021883] Descriptio…	Arthrex, Inc.	2001	—
*	K021883	Biofastin RC Threaded Suture Anchor Summary page 1 …Model AR-i 9208 [501 (k) Number K003227] Mitek Worldwide Biofastin RC Threaded Suture Anchor [510(k) Number K021883] Description The device described in this submission is designed with a corkscrew style thread and will be made available initia…	Mitek Worldwide	2002	—

Also cleared against K003227: 7 other devices →

What descends from it? (14)

See all 14

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051983	Model 3000 Axyaloop Bio-Absorbable Bone Anchor	Axya Medical, Inc.	2005	11
K051250	Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor	Axya Medical, Inc.	2005	11
K060970	Axyaloop Nonabsorbable Bone Anchor	Axya Medical, Inc.	2006	10
K083268	Tornier, Inc., Insite Suture Anchors	Tornier, Inc.	2009	7
K061949	Doubleplay Suture Anchor	Biocomposites, Ltd.	2006	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K051983 (Axya Medical, Inc., 2005) has gone furthest, with 11 descendants of its own.
7 other devices also cite its predicate K003227.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAI

8in 2025

2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007high 191 (2016) · low 34 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAI

40in 2020

2007high 40 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAI

2,148in 2025

2007high 2,300 (2024) · low 88 (2009)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 5000 AxyaLoop TM 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 (121 words)

The Axya Model 5000 AxyaLoop TM 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/K041698 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041698: Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable 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/K041698

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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