510(k) · Cleared

Cleared

Axya, Model 3000 Axyzloop Titanium Bone Anchor

K070773510(k) TraditionalCleared Oct 11, 2007204-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 11, 2007 as substantially equivalent to K022207 (Axya Medical, Inc., 2002) and 1 other predicate after a 204-day review. Its family tree reaches back 2 generations to 1992.

Decided: Oct 11, 2007
Review: 204 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K915889 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK915889 Mitek Bone Anchor, ModificationMitek Surgical Products, Inc. · 1992
1 generation backK041115 Gii Quickanchor PlusDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
This deviceK070773 Axya, Model 3000 Axyzloop Titanium Bone AnchorAxya Medical, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K915889	Mitek Bone Anchor, Modification	Mitek Surgical Products, Inc.	1992	—
−1	K041115	Gii Quickanchor Plus	Depuy Mitek, A Johnson & Johnson Company	2004	1
0 (this device)	K070773	Axya, Model 3000 Axyzloop Titanium Bone Anchor	Axya Medical, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K070773, 1992–2007Source: 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

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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
*	K022207	Axya Model 3000 Axyaloop Titanium Bone Anchor System Summary page 1 …Product code: MBI - Class 11 Predicate Devices Axya Medical, Inc. Model 3000 AxyaLoopTM Suture Anchor [501(k) Number K022207] Depuy Mitek QUICKANCHOR Plus Bone Anchor 1510(k) Number K041115] Description The device…	Axya Medical, Inc.	2002	—
*	K041115	Gii Quickanchor Plus Summary page 1 …000 AxyaLoopTM Suture Anchor [501(k) Number K022207] Depuy Mitek QUICKANCHOR Plus Bone Anchor 1510(k) Number K041115] Description The device described in this submission is designed with a corkscrew style thread and is available in a 2.0 mm diam…	Depuy Mitek, A Johnson & Johnson Company	2004	1

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
1 of the 3 ancestors has a recall of any class.

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. 2007, this device’s year, is highlighted.

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 AxyaLoopTM Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture or size 3/0 TephaFLEX TM 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/K070773 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070773: Axya, Model 3000 Axyzloop Titanium 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/K070773

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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