510(k) · Cleared

Cleared

Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000

K011912510(k) TraditionalCleared Aug 31, 200173-day reviewClass II21 CFR 888.3040

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

Axya Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Aug 31, 2001 as substantially equivalent to K983818 (Mitek Products, 1998) after a 73-day review. Its family tree reaches back 1 generation to 1998. 10 later devices descend from it.

Decided: Aug 31, 2001
Review: 73 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K983818 (1998). 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK983818 Mitek Fastin RC AnchorMitek Products · 1998
This deviceK011912 Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000Axya Medical, Inc. · 2001
Descendant · cites it directly · 9 of its ownK052491 Axya Model 6500 Axyaloop Self-Tapping Bone AnchorAxya Medical, Inc. · 2005 · 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 10 descendants. See all descendants

Descendants cleared per year

2005high 2 (2013) · low 0 (2006)2026

Most influential descendants

Showing 5 of 10 · See all

K052491Axya Model 6500 Axyaloop Self-Tapping Bone AnchorAxya Medical, Inc. · 2005 · cites it directly9descendants
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
−1	K983818	Mitek Fastin RC Anchor	Mitek Products	1998	—
0 (this device)	K011912	Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000	Axya Medical, Inc.	2001	—
+1	K052491	Axya Model 6500 Axyaloop Self-Tapping Bone Anchor	Axya Medical, Inc.	2005	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	1	0
2010	1	0
2011	1	0
2013	2	0
2014	1	0
2015	1	0
2020	1	0
2026	1	0

FIG. 1 — Lineage of K011912, 1998–2026Source: 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 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

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What was it cleared against? (1)

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
*	K983818	Mitek Fastin RC Anchor Summary page 2 …e Axya Model 2000 AxyalLoop Self-Tapping Bone Anchor is substantially equivalent to previously cleared devices, including the Mitek Fastin ® Suture Anchor [501(k) Number K983818]. The 510(k) Notice contains summaries of in vitro studies which were conducted to evaluate the anchor pull-out strength as spec…	Mitek Products	1998	—

Also cleared against K983818: 1 other device →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K052491	Axya Model 6500 Axyaloop Self-Tapping Bone Anchor	Axya Medical, Inc.	2005	9
K083268	Tornier, Inc., Insite Suture Anchors	Tornier, Inc.	2009	7

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?

Its one ancestor has no recall.
Of its descendants, K052491 (Axya Medical, Inc., 2005) has gone furthest, with 9 descendants of its own.
1 other device also cites its predicate K983818.

How does its category compare?

All MBI devices

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

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007high 3,826 (2025) · low 240 (2007)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 2000 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing

synthetic monofilament non-absorbable suture to bone. This device is intended for use in

repair of shoulder injuries. The 5mm anchor 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K011912 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011912: Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011912

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026