510(k) · Cleared

Cleared

Helical Compression Anchor System, Cannulated, Version 2

K013903510(k) SpecialCleared Dec 17, 200121-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

Triad Medical, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 17, 2001 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Dec 17, 2001
Review: 21 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK013903 Helical Compression Anchor System, Cannulated, Version 2Triad Medical, Inc. · 2001
Descendant · cites it directly · 1 of its ownK042244 Bone-Lok MVP Cortical-Cancellous Compression DeviceTriage Medical, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK070393 Lagwire SystemFxdevices · 2007

Most influential descendants

Showing 2 of 2 · See all

K042244Bone-Lok MVP Cortical-Cancellous Compression DeviceTriage Medical, Inc. · 2004 · cites it directly1descendant
K070393Lagwire SystemFxdevices · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013903	Helical Compression Anchor System, Cannulated, Version 2	Triad Medical, Inc.	2001	—
+1	K042244	Bone-Lok MVP Cortical-Cancellous Compression Device	Triage Medical, Inc.	2004	—
+2	K070393	Lagwire System	Fxdevices	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0

FIG. 1 — Lineage of K013903, 2001–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042244	Bone-Lok MVP Cortical-Cancellous Compression Device	Triage Medical, Inc.	2004	1

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, K042244 (Triage Medical, Inc., 2004) has gone furthest, with 1 descendant 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	—

What is it indicated for?

This device is used in the general management of fractures and reconstructive surgery.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013903 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013903: Helical Compression Anchor System, Cannulated, Version 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013903

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026