510(k) · Cleared

Cleared

Biofix Biodegradable Meniscus Arrow System

K955768510(k) TraditionalCleared Mar 4, 199673-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

Bioscience, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Mar 4, 1996 as substantially equivalent to K925573 (Acufex Microsurgical, Inc., 1993) and 1 other predicate after a 73-day review. Its family tree reaches back 1 generation to 1993. 6 later devices descend from it.

Decided: Mar 4, 1996
Review: 73 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K925573 (1993). 2 ancestors in all. 6 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
This deviceK955768 Biofix Biodegradable Meniscus Arrow SystemBioscience, Inc. · 1996
Descendant · cites it directly · 2 of its ownK993453 Meniscus Arrow, Models 531110, 531113, 531116Bionx Implants, Ltd. · 1999
Descendant · cites it directly · 1 of its ownK012334 Contour Meniscus Arrow, Models 541110, 541113, and 541116Bionx Implants, Inc. · 2001
Descendant · cites it directly · 0 of its ownK053492 BioductBioduct, LLC · 2007
Descendant · cites it directly · 0 of its ownK031714 Inion Trinion Biodegradable Meniscus ScrewInion, Ltd. · 2004
Descendant · 2 generations on · 0 of its ownK041128 Suture ArrowLinvatec Corp. · 2004

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1998high 2 (2004) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all

K993453Meniscus Arrow, Models 531110, 531113, 531116Bionx Implants, Ltd. · 1999 · cites it directly2descendants
K012334Contour Meniscus Arrow, Models 541110, 541113, and 541116Bionx Implants, Inc. · 2001 · cites it directly1descendant
K053492BioductBioduct, LLC · 2007 · cites it directly0descendants
K031714Inion Trinion Biodegradable Meniscus ScrewInion, Ltd. · 2004 · cites it directly0descendants
K041128Suture ArrowLinvatec Corp. · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925573	Acufex T-Bar	Acufex Microsurgical, Inc.	1993	1
0 (this device)	K955768	Biofix Biodegradable Meniscus Arrow System	Bioscience, Inc.	1996	—
+1	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	—
+1	K053492	Bioduct	Bioduct, LLC	2007	—
+1	K031714	Inion Trinion Biodegradable Meniscus Screw	Inion, Ltd.	2004	—
+2	K041128	Suture Arrow	Linvatec Corp.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2001	1	0
2004	2	0
2007	1	0

FIG. 1 — Lineage of K955768, 1993–2007Source: 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 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? (3)

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
*	K925573	Acufex T-Bar Summary page 1 …Devices Davis & Geck Maxon Monofilament Polyglyconate Synthetic Absorbable Surgical Sutures (PMA G840051) (Maxon sutures) Acufex Microsurgical, Inc. T-Fix Suture Bar (K925573) and implantation instruments (K942442) (T-Fix Meniscus Fixation System) (1 B \\\DC - 63547/1 - 0208366.01 Inte…	Acufex Microsurgical, Inc.	1993	1
*	K942442	Acufex T-Fix Delivery System Summary page 1 …nt Polyglyconate Synthetic Absorbable Surgical Sutures (PMA G840051) (Maxon sutures) Acufex Microsurgical, Inc. T-Fix Suture Bar (K925573) and implantation instruments (K942442) (T-Fix Meniscus Fixation System) (1 B \\\DC - 63547/1 - 0208366.01 Intended Use The BIOFIX® Meniscus Arrow Sy…	Acufex Microsurgical, Inc.	1994	—
*	—	Davis & Geck Maxon Monofilament Polyglyconate Synthetic Absorbable Surgical Sutures… Named without a submission number			—

Also cleared against K925573: 2 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K993453	Meniscus Arrow, Models 531110, 531113, 531116	Bionx Implants, Ltd.	1999	2
K012334	Contour Meniscus Arrow, Models 541110, 541113, and 541116	Bionx Implants, Inc.	2001	1
K053492	Bioduct	Bioduct, LLC	2007	0
K031714	Inion Trinion Biodegradable Meniscus Screw	Inion, Ltd.	2004	0
K974538	Meniscal Repair Device	Linvatec Corp.	1998	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K993453 (Bionx Implants, Ltd., 1999) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K925573.

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 BIOFIX® Meniscus Arrow System is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (e.g., “red-red” and “red-white” area) in conjunction with appropriate immobihization.

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/K955768 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955768: Biofix Biodegradable Meniscus Arrow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955768

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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