510(k) · Cleared

Cleared

Suture Arrow

K041128510(k) TraditionalCleared Jul 29, 200490-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

Linvatec Corp. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jul 29, 2004 as substantially equivalent to K983577 (Arthrex, Inc., 1999) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1993.

Decided: Jul 29, 2004
Review: 90 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K925573 (1993). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
3 generations backK955768 Biofix Biodegradable Meniscus Arrow SystemBioscience, Inc. · 1996
2 generations backK993453 Meniscus Arrow, Models 531110, 531113, 531116Bionx Implants, Ltd. · 1999
1 generation backK012334 Contour Meniscus Arrow, Models 541110, 541113, and 541116Bionx Implants, Inc. · 2001
This deviceK041128 Suture ArrowLinvatec Corp. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K925573	Acufex T-Bar	Acufex Microsurgical, Inc.	1993	1
−3	K955768	Biofix Biodegradable Meniscus Arrow System	Bioscience, Inc.	1996	—
−2	K993453	Meniscus Arrow, Models 531110, 531113, 531116	Bionx Implants, Ltd.	1999	—
−1	K012334	Contour Meniscus Arrow, Models 541110, 541113, and 541116	Bionx Implants, Inc.	2001	—
0 (this device)	K041128	Suture Arrow	Linvatec Corp.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1999	1	0

FIG. 1 — Lineage of K041128, 1993–2004Source: 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

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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
*	K983577	Arthrex Meniscal Dart System Summary page 1 …Proposed Class/Device: Class II Product Code MAI, GAT D. Predicate/Legally Marketed Devices Arthrex Meniscal Dart System 510(k) # K983577 Contour Meniscus Arrow 510(k) # K012334 Summary of Safety and Effectiveness Suture Arrow 510…	Arthrex, Inc.	1999	—
*	K012334	Contour Meniscus Arrow, Models 541110, 541113, and 541116 Summary page 1 …MAI, GAT D. Predicate/Legally Marketed Devices Arthrex Meniscal Dart System 510(k) # K983577 Contour Meniscus Arrow 510(k) # K012334 Summary of Safety and Effectiveness Suture Arrow 510(k)# <Q049/l/,- April 27, 2004 Page 2 of 4 E. Device De…	Bionx Implants, Inc.	2001	—

Also cleared against K983577: 3 other devices →

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 11 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
1 of the 6 ancestors has a recall of any class.
3 other devices also cite its predicate K983577.

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 Suture Arrow is indicated for use in repairs of knee meniscus tears that would otherwise be considered for standard repair using suture.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041128 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041128: Suture Arrow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041128

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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