510(k) · Cleared

Cleared

Smith & Nephew GTS Sleeve and GTS Tapered Screw

K040542510(k) TraditionalCleared Aug 19, 2004170-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 Aug 19, 2004 as substantially equivalent to K983560 (Innovasive Devices, Inc., 1999) and 2 other predicates after a 170-day review. Its family tree reaches back 4 generations to 1993. 3 later devices descend from it.

Decided: Aug 19, 2004
Review: 170 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K915424 (1993). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
3 generations backK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
2 generations backK992396 Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000
1 generation backK032224 Biorci ScrewSmith & Nephew, Inc. · 2003
This deviceK040542 Smith & Nephew GTS Sleeve and GTS Tapered ScrewSmith & Nephew, Inc. · 2004
Descendant · cites it directly · 1 of its ownK093943 Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div. · 2010
Descendant · 2 generations on · 0 of its ownK230874 Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd. · 2023
Descendant · cites it directly · 0 of its ownK143172 ACL SMART SystemSmith & Nephew, Inc. · 2015

Most influential descendants

Showing 3 of 3 · See all

K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div. · 2010 · cites it directly1descendant
K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd. · 2023 · 2 generations on0descendants
K143172ACL SMART SystemSmith & Nephew, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K915424	Arthrex Cannulated Interference Screw	Arthrex, Inc.	1993	—
−3	K980841	Rci Fixation Screws	Smith & Nephew, Inc.	1998	—
−2	K992396	Biorci Screw	Smith & Nephew Endoscopy, Inc.	2000	—
−1	K032224	Biorci Screw	Smith & Nephew, Inc.	2003	—
0 (this device)	K040542	Smith & Nephew GTS Sleeve and GTS Tapered Screw	Smith & Nephew, Inc.	2004	—
+1	K093943	Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MM	Smith & Nephew Inc., Endoscopy Div.	2010	—
+2	K230874	Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath	Suzhou Endophix Co., Ltd.	2023	—
+1	K143172	ACL SMART System	Smith & Nephew, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1999	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2015	1	0
2023	1	0

FIG. 1 — Lineage of K040542, 1993–2023Source: 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 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? (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
*	K983560	Innovasive Devices Intratunnel Tibial Fixation Fastener Summary page 1 …apered Screw, manufactured by Innovasive Devices, Inc. (acquired by Johnson & Johnson, November 1999) and found substantially equivalent on 28 January 1999 under K983560. In addition, the proposed GTS Tapered Screw is substantially equivalent to Smith & Nephew, Inc. K032224 (SE 08/05/03) an…	Innovasive Devices, Inc.	1999	—
*	K032224	Biorci Screw Summary page 1 …found substantially equivalent on 28 January 1999 under K983560. In addition, the proposed GTS Tapered Screw is substantially equivalent to Smith & Nephew, Inc. K032224 (SE 08/05/03) and K992396 (SE 01/12/00) BioRCI® Screws E. Description of Device The Smith & Nephew GTS Sleeve and GTS Taper…	Smith & Nephew, Inc.	2003	—
*	K992396	Biorci Screw Summary page 1 …alent on 28 January 1999 under K983560. In addition, the proposed GTS Tapered Screw is substantially equivalent to Smith & Nephew, Inc. K032224 (SE 08/05/03) and K992396 (SE 01/12/00) BioRCI® Screws E. Description of Device The Smith & Nephew GTS Sleeve and GTS Tapered Screw consist of two (2…	Smith & Nephew Endoscopy, Inc.	2000	—

Also cleared against K983560: 6 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K093943	Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MM	Smith & Nephew Inc., Endoscopy Div.	2010	1
K143172	ACL SMART System	Smith & Nephew, Inc.	2015	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?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K093943 (Smith & Nephew Inc., Endoscopy Div., 2010) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K983560.

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	—

What is it indicated for?

The Smith & Nephew GTS Sleeve and GTS Tapered Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040542 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040542: Smith & Nephew GTS Sleeve and GTS Tapered Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040542

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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