510(k) · Cleared

Cleared

Arthrex Cannulated Interference Screw

K915424510(k) TraditionalCleared Feb 9, 1993435-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

Arthrex, Inc. · HWC Screw, Fixation, Bone

Cleared on Feb 9, 1993 after a 435-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 97 later devices descend from it.

Decided: Feb 9, 1993
Review: 435 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

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

This deviceK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
Descendant · cites it directly · 95 of its ownK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
Descendant · 2 generations on · 86 of its ownK992396 Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000
Descendant · 3 generations on · 71 of its ownK051310 PLC ScrewSmith & Nephew, Inc. · 2005 · Recalled
Descendant · 4 generations on · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
Descendant · 5 generations on · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016

Showing 5 of 97 descendants. See all descendants

Descendants cleared per year

1997high 11 (2023) · low 0 (2001)2026

Most influential descendants

Showing 5 of 97 · See all

K980841Rci Fixation ScrewsSmith & Nephew, Inc. · 1998 · cites it directly95descendants
K992396Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000 · 2 generations on86descendants
K051310PLC ScrewSmith & Nephew, Inc. · 2005 · 3 generations on71descendants
K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · 4 generations on47descendants
K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 5 generations on38descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K915424	Arthrex Cannulated Interference Screw	Arthrex, Inc.	1993	—
+1	K980841	Rci Fixation Screws	Smith & Nephew, Inc.	1998	—
+2	K992396	Biorci Screw	Smith & Nephew Endoscopy, Inc.	2000	—
+3	K051310	PLC Screw	Smith & Nephew, Inc.	2005	24
+4	K071176	Modification to: Arthrex Interference Screw	Arthrex, Inc.	2007	—
+5	K151342	Arthrex SwiveLock Anchors	Arthrex, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2003	2	0
2004	2	0
2005	1	0
2007	1	0
2008	2	0
2009	3	0
2010	1	0
2011	3	0
2012	1	0
2013	2	0
2014	3	0
2015	5	0
2016	2	0
2017	2	0
2018	5	0
2019	5	0
2020	8	0
2021	8	0
2022	4	0
2023	11	0
2024	4	0
2025	10	0
2026	8	0

FIG. 1 — Lineage of K915424, 1993–2026Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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?

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

What descends from it? (97)

See all 97

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

Number	Device	Applicant	Decided	Descendants
K980841	Rci Fixation Screws	Smith & Nephew, Inc.	1998	95
K031937	Alantech Graft Fixation Screw	Arthrocare Corp.	2003	0
K972599	Acufex Screw Cannula	Smith & Nephew Endoscopy, Inc.	1997	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, K980841 (Smith & Nephew, Inc., 1998) has gone furthest, with 95 descendants of its own.

How does its category compare?

All HWC devices

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

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

https://510kreport.com/device/K915424 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915424: Arthrex Cannulated Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915424

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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