510(k) · Cleared

Cleared

Axya Model 3000 Axyaloop Titanium Bone Anchor System

K022207510(k) TraditionalCleared Oct 4, 200288-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 Oct 4, 2002 after an 88-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 1 later device descends from it.

Decided: Oct 4, 2002
Review: 88 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 2

1 later device descends from it, 1 citing it directly.

This deviceK022207 Axya Model 3000 Axyaloop Titanium Bone Anchor SystemAxya Medical, Inc. · 2002
Descendant · cites it directly · 0 of its ownK070773 Axya, Model 3000 Axyzloop Titanium Bone AnchorAxya Medical, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K070773Axya, Model 3000 Axyzloop Titanium Bone AnchorAxya Medical, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K022207	Axya Model 3000 Axyaloop Titanium Bone Anchor System	Axya Medical, Inc.	2002	—
+1	K070773	Axya, Model 3000 Axyzloop Titanium Bone Anchor	Axya Medical, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K022207, 2002–2007Source: 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

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K039711	Axya Medical, Inc. Model 1000 AxyaLoop Suture Anchor Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1 …BI Class II Predicate Devices Axya Medical, Inc. Model 1000 AxyaLoopTMSuture Anchor [501(k) Number KO039711 Orthopaedic Biosystems Mini Tac 2.0 mm Bone Anchor [51O(k) Number KO007971 Descrip…
Kept off the family tree	K007971	Orthopaedic Biosystems Mini Tac 2.0 mm Bone Anchor Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1 …re Anchor [501(k) Number KO039711 Orthopaedic Biosystems Mini Tac 2.0 mm Bone Anchor [51O(k) Number KO007971 Description The device described in this submission is designed with a corkscrew style thread and is available in a 2.0 mm dia…

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K070773	Axya, Model 3000 Axyzloop Titanium Bone Anchor	Axya Medical, Inc.	2007	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?

Of its descendants, K070773 (Axya Medical, Inc., 2007) has gone furthest, with 0 descendants of its own.

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 3000 AxyaLoop Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture in repairs of the extremities such as those shown below:

Foot and Ankle

1 Hallux Valgus repairs

2 Medial or lateral instability repairs/reconstructions

3 Achilles tendon repairs/reconstructions

4 Midfoot reconstructions

5 Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist and Hand

1 Scapholunate ligament reconstructions

2 Ulnar and radial collateral ligament reconstructions

3 Lateral epicondylitis repair

4 Biceps tendon reattachment

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022207 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022207: Axya Model 3000 Axyaloop Titanium Bone Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022207

Report an extraction error

Are you the manufacturer?

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