510(k) · Cleared

Cleared

Titanium Alloy Bone Screws

K940207510(k) TraditionalCleared Jul 12, 1994179-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

Aesculap, Inc. · HWC Screw, Fixation, Bone

Cleared on Jul 12, 1994 after a 179-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 66 later devices descend from it.

Decided: Jul 12, 1994
Review: 179 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

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

This deviceK940207 Titanium Alloy Bone ScrewsAesculap, Inc. · 1994
Descendant · cites it directly · 61 of its ownK960533 K3 Bone Screw SystemKinetikos Medical, Inc. · 1996
Descendant · cites it directly · 41 of its ownK960537 K2 Bone Screw SystemKinetikos Medical, Inc. · 1996
Descendant · 2 generations on · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
Descendant · 3 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
Descendant · 4 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

1996high 9 (2022) · low 0 (2000)2026

Most influential descendants

Showing 5 of 66 · See all

K960533K3 Bone Screw SystemKinetikos Medical, Inc. · 1996 · cites it directly61descendants
K960537K2 Bone Screw SystemKinetikos Medical, Inc. · 1996 · cites it directly41descendants
K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · 2 generations on39descendants
K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 3 generations on36descendants
K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 4 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940207	Titanium Alloy Bone Screws	Aesculap, Inc.	1994	—
+1	K960533	K3 Bone Screw System	Kinetikos Medical, Inc.	1996	—
+1	K960537	K2 Bone Screw System	Kinetikos Medical, Inc.	1996	—
+2	K120493	Mini Cannulated Headed and Headless Screw Set	Instratek, Inc.	2012	1
+3	K123890	Acumed Cannulated Screw System	Acumed, LLC	2013	2
+4	K190586	Monster® Screw System	Paragon 28, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	1	0
1998	1	0
1999	1	0
2003	1	0
2005	1	0
2012	1	0
2013	3	0
2015	2	0
2016	1	0
2017	6	0
2018	2	0
2019	7	0
2020	6	0
2021	2	0
2022	9	0
2023	9	0
2024	3	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K940207, 1994–2026Source: 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? (66)

See all 66

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

Number	Device	Applicant	Decided	Descendants
K960533	K3 Bone Screw System	Kinetikos Medical, Inc.	1996	61
K960537	K2 Bone Screw System	Kinetikos Medical, Inc.	1996	41
K990019	DRG Medium Screw System	Dolphin Medical Technologies, Inc.	1999	0
K973810	DRG Large Screw System	Dolphin Medical Technologies, Inc.	1998	0
K972217	Orthopedic Screw System	Ferguson Medical	1997	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, K960533 (Kinetikos Medical, Inc., 1996) has gone furthest, with 61 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/K940207 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940207: Titanium Alloy Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940207

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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