510(k) · Cleared

Cleared

Acufex Suretac

K931519510(k) TraditionalCleared Jun 16, 1994447-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

Acufex Microsurgical, Inc. · JDR Staple, Fixation, Bone

Cleared on Jun 16, 1994 after a 447-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 50 later devices descend from it.

Decided: Jun 16, 1994
Review: 447 days
Class: Class II
Product code: JDR
Recalls: None
Predicates: 0

50 later devices descend from it, 3 citing it directly.

This deviceK931519 Acufex SuretacAcufex Microsurgical, Inc. · 1994
Descendant · cites it directly · 47 of its ownK012572 Soft Tissue Screw and WasherBiomet, Inc. · 2001
Descendant · 2 generations on · 26 of its ownK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
Descendant · 2 generations on · 15 of its ownK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
Descendant · 3 generations on · 13 of its ownK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
Descendant · 2 generations on · 9 of its ownK070389 Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · Recalled

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2001high 6 (2011) · low 0 (2003)2026

Most influential descendants

Showing 5 of 50 · See all

K012572Soft Tissue Screw and WasherBiomet, Inc. · 2001 · cites it directly47descendants
K041274Resorbable Interference ScrewArthrotek, Inc. · 2004 · 2 generations on26descendants
K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc. · 2004 · 2 generations on15descendants
K052080Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005 · 3 generations on13descendants
K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K931519	Acufex Suretac	Acufex Microsurgical, Inc.	1994	—
+1	K012572	Soft Tissue Screw and Washer	Biomet, Inc.	2001	—
+2	K041274	Resorbable Interference Screw	Arthrotek, Inc.	2004	5
+2	K032894	Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T…	Linvatec Biomaterials, Inc.	2004	—
+3	K052080	Matryx Interference Screw	Linvatec Biomaterials, Inc.	2005	—
+2	K070389	Peek Knotless Anchors	Biomet Sports Medicine, Inc.	2007	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2004	4	0
2005	2	0
2006	2	0
2007	4	0
2008	3	0
2009	1	0
2010	2	0
2011	6	0
2012	3	0
2013	4	0
2014	2	0
2015	1	0
2016	2	0
2017	2	0
2018	3	0
2020	4	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K931519, 1994–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDR? 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 JDR device

#1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (50)

See all 50

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

Number	Device	Applicant	Decided	Descendants
K012572	Soft Tissue Screw and Washer	Biomet, Inc.	2001	47
K020948	Smith & Nephew Suretac - Expanded Indications II	Smith & Nephew, Inc.	2002	1
K023417	Suretac Iii, Models 7209900, 7209901	Smith & Nephew, Inc.	2002	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, K012572 (Biomet, Inc., 2001) has gone furthest, with 47 descendants of its own.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDR

3in 2025

2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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	8	70	0	3
2008	5	89	1	14
2009	0	—	0	10
2010	2	—	0	35
2011	1	—	0	62
2012	1	—	0	34
2013	9	137	0	27
2014	11	97	0	49
2015	7	111	1	48
2016	6	101	0	76
2017	9	172	0	116
2018	8	107	1	239
2019	5	149	0	242
2020	4	161	1	234
2021	3	62	0	210
2022	5	107	11	202
2023	9	72	0	175
2024	4	29	0	206
2025	3	65	0	314
2026	2	—	2	—

https://510kreport.com/device/K931519 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931519: Acufex Suretac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931519

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026