510(k) · Cleared

Cleared

Acutract

K930834510(k) TraditionalCleared Jul 26, 1993159-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

Acu Med, Inc. · HWC Screw, Fixation, Bone

Cleared on Jul 26, 1993 after a 159-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 219 later devices descend from it.

Decided: Jul 26, 1993
Review: 159 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

219 later devices descend from it, 5 citing it directly.

This deviceK930834 AcutractAcu Med, Inc. · 1993
Descendant · cites it directly · 145 of its ownK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
Descendant · 2 generations on · 144 of its ownK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
Descendant · 3 generations on · 143 of its ownK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
Descendant · 3 generations on · 139 of its ownK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
Descendant · 3 generations on · 134 of its ownK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013

Showing 5 of 219 descendants. See all descendants

Descendants cleared per year

2003high 36 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 219 · See all

K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · cites it directly145descendants
K080398SI Joint Fusion SystemSI-BONE, Inc. · 2008 · 2 generations on144descendants
K110838Ifuse Implant SystemSI-BONE, Inc. · 2011 · 3 generations on143descendants
K122074Ifuse Implant SystemSI-BONE, Inc. · 2012 · 3 generations on139descendants
K123850Ifuse Implant SystemSI-BONE, Inc. · 2013 · 3 generations on134descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K930834	Acutract	Acu Med, Inc.	1993	—
+1	K051309	Roi Fusion Rods & Plates	Reiley Orthopaedics, Inc.	2005	2
+2	K080398	SI Joint Fusion System	SI-BONE, Inc.	2008	—
+3	K110838	Ifuse Implant System	SI-BONE, Inc.	2011	—
+3	K122074	Ifuse Implant System	SI-BONE, Inc.	2012	—
+3	K123850	Ifuse Implant System	SI-BONE, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2008	1	0
2009	1	0
2011	1	0
2012	3	0
2013	4	0
2014	4	0
2015	11	0
2016	9	0
2017	11	0
2018	3	0
2019	7	0
2020	11	0
2021	15	0
2022	20	0
2023	36	0
2024	29	0
2025	25	0
2026	26	0

FIG. 1 — Lineage of K930834, 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? (219)

See all 219

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

Number	Device	Applicant	Decided	Descendants
K051309	Roi Fusion Rods & Plates	Reiley Orthopaedics, Inc.	2005	145
K030706	Ebi Dynafix Compression Bone Screw	Ebi, L.P.	2003	69
K242973	CanMINI Hand and Foot System	Canwell Medical Co., Ltd.	2025	0
K221333	Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional	Acumed, LLC	2022	0
K160791	AmorChem Titanium Porous Fixation Device	Amorchem Holdings, Inc.	2016	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, K051309 (Reiley Orthopaedics, Inc., 2005) has gone furthest, with 145 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/K930834 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930834: Acutract.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930834

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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