510(k) · Cleared

Cleared

Smith & Nephew Suture Hapla Interference Screw

K002274510(k) TraditionalCleared Mar 7, 2001224-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

Smith & Nephew, Inc. · HWC Screw, Fixation, Bone

Cleared on Mar 7, 2001 after a 224-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 72 later devices descend from it.

Decided: Mar 7, 2001
Review: 224 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

72 later devices descend from it, 4 citing it directly.

This deviceK002274 Smith & Nephew Suture Hapla Interference ScrewSmith & Nephew, Inc. · 2001
Descendant · cites it directly · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
Descendant · 2 generations on · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
Descendant · 3 generations on · 29 of its ownK171141 Arthrex SwiveLock AnchorsArthrex, Inc. · 2017
Descendant · 3 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
Descendant · cites it directly · 22 of its ownK080358 Plla, HA ScrewSmith & Nephew Inc., Endoscopy Div. · 2008 · Recalled

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2007high 10 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 72 · See all

K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · cites it directly47descendants
K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 2 generations on38descendants
K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 3 generations on29descendants
K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 3 generations on28descendants
K080358Plla, HA ScrewSmith & Nephew Inc., Endoscopy Div. · 2008 · cites it directly22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002274	Smith & Nephew Suture Hapla Interference Screw	Smith & Nephew, Inc.	2001	—
+1	K071176	Modification to: Arthrex Interference Screw	Arthrex, Inc.	2007	—
+2	K151342	Arthrex SwiveLock Anchors	Arthrex, Inc.	2016	—
+3	K171141	Arthrex SwiveLock Anchors	Arthrex, Inc.	2017	—
+3	K180768	Arthrex SwiveLock Anchors	Arthrex, Inc.	2018	—
+1	K080358	Plla, HA Screw	Smith & Nephew Inc., Endoscopy Div.	2008	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2009	1	0
2010	1	0
2011	1	0
2012	1	0
2014	3	0
2015	4	0
2016	1	0
2017	1	0
2018	5	0
2019	5	0
2020	8	0
2021	3	0
2022	4	0
2023	10	0
2024	4	0
2025	9	0
2026	8	0

FIG. 1 — Lineage of K002274, 2001–2026Source: 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (72)

See all 72

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

Number	Device	Applicant	Decided	Descendants
K071176	Modification to: Arthrex Interference Screw	Arthrex, Inc.	2007	47
K080358	Plla, HA Screw	Smith & Nephew Inc., Endoscopy Div.	2008	22
K122596	Arthroscopic Surgical Instruments - Interference Screw Systems	Smith & Nephew, Inc.	2012	0
K081390	Bioactif Osteotrans Interfence Screw	Takiron Co., Ltd.	2008	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, K071176 (Arthrex, Inc., 2007) has gone furthest, with 47 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/K002274 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002274: Smith & Nephew Suture Hapla Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002274

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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