510(k) · Cleared

Cleared

Acute Bone Screw

K061206510(k) TraditionalCleared Jun 19, 200649-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

Acute Innovations, LLC · HWC Screw, Fixation, Bone

Cleared on Jun 19, 2006 as substantially equivalent to K024169 (Macropore Biosurgery, Inc., 2003) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 1994. 33 later devices descend from it.

Decided: Jun 19, 2006
Review: 49 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K942340 (1994). 2 ancestors in all. 33 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK942340 Cortical Bone ScrewAcu Med, Inc. · 1994 · Recalled
This deviceK061206 Acute Bone ScrewAcute Innovations, LLC · 2006
Descendant · cites it directly · 32 of its ownK073556 Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008
Descendant · 2 generations on · 26 of its ownK133616 Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014
Descendant · 3 generations on · 23 of its ownK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
Descendant · 4 generations on · 13 of its ownK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
Descendant · 4 generations on · 11 of its ownK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2008high 6 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 33 · See all

K073556Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008 · cites it directly32descendants
K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014 · 2 generations on26descendants
K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015 · 3 generations on23descendants
K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015 · 4 generations on13descendants
K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016 · 4 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K942340	Cortical Bone Screw	Acu Med, Inc.	1994	3
0 (this device)	K061206	Acute Bone Screw	Acute Innovations, LLC	2006	—
+1	K073556	Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos	Medxpert GmbH	2008	—
+2	K133616	Matrixrib Fixation System	Synthes (USA) Products, LLC	2014	—
+3	K142823	Biomet Microfixation Thoracic Fixation System	Biomet Microfixation	2015	—
+4	K151173	Biomet Microfixation RibFix Blu Thoracic Fixation System	Biomet Microfixation	2015	—
+4	K152253	Biomet Microfixation RibFix Blu Thoracic Fixation System	Biomet Microfixation	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2012	1	0
2014	2	0
2015	2	0
2016	4	0
2018	1	0
2019	3	0
2021	1	0
2022	2	0
2023	3	0
2024	4	0
2025	3	0
2026	6	0

FIG. 1 — Lineage of K061206, 1994–2026Source: 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? (2)

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
*	K024169	Macropore OS Reconstruction Summary page 1 …atory Class: Class II, 21 CFR 888.3040 Device Product Code: HWC Legally Marketed Equivalent Device(s): Macropore OS Reconstruction System K024169 Acumed Cortical Bone Screw K942340 Device Description: The Acute Bone Screws consists of…	Macropore Biosurgery, Inc.	2003	—
*	K942340	Cortical Bone Screw Summary page 1 …HWC Legally Marketed Equivalent Device(s): Macropore OS Reconstruction System K024169 Acumed Cortical Bone Screw K942340 Device Description: The Acute Bone Screws consists of bone screws of varying lengths. The screws are partially and fully threaded…	Acu Med, Inc.	1994	3

Also cleared against K024169: 2 other devices →

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K073556	Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos	Medxpert GmbH	2008	32

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K073556 (Medxpert GmbH, 2008) has gone furthest, with 32 descendants of its own.
2 other devices also cite its predicate K024169.

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 Acute Bone Screw is a general purpose screw intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the thorax (ribs, sternum, clavicle, scapula).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061206 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061206: Acute Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061206

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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