510(k) · Cleared

Cleared

Ace Bone Screw Nut

K874669510(k) TraditionalCleared Dec 11, 198728-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Buckman Co., Inc. · HTN Washer, Bolt Nut

Cleared on Dec 11, 1987 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 138 devices in its family, counting itself, has a Class I recall. 137 later devices descend from it.

Decided: Dec 11, 1987
Review: 28 days
Class: Class II
Product code: HTN
Recalls: None
Predicates: 0

137 later devices descend from it, 1 citing it directly. 1 of the 138 devices in this family, counting this one, has a Class I recall.

This deviceK874669 Ace Bone Screw NutBuckman Co., Inc. · 1987
Descendant · cites it directly · 136 of its ownK983265 Depuy Ace Composite Locking NutDepuy Ace Medical Co. · 1998
Descendant · 2 generations on · 135 of its ownK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
Descendant · 3 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
Descendant · 4 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
Descendant · 5 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled

Showing 5 of 137 descendants. See all descendants

Descendants cleared per year

1998high 26 (2026) · low 0 (1999)2026

Class I recalls in this family

K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 137 · See all

K983265Depuy Ace Composite Locking NutDepuy Ace Medical Co. · 1998 · cites it directly136descendants
K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · 2 generations on135descendants
K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 3 generations on79descendants
K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 4 generations on74descendants
K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 5 generations on69descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K874669	Ace Bone Screw Nut	Buckman Co., Inc.	1987	—
+1	K983265	Depuy Ace Composite Locking Nut	Depuy Ace Medical Co.	1998	—
+2	K112885	Zimmer Plates and Screws System Screws Only	Zimmer, Inc.	2011	15
+3	K143039	CrossRoads Screw System	Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem	2015	—
+4	K162825	CAPTIVATE™ Compression Screws	Globus Medical, Inc.	2017	—
+5	K171651	Excelsius GPS	Globus Medical, Inc.	2017	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2011	1	0
2013	1	0
2014	3	0
2015	10	0
2016	2	0
2017	5	0
2018	2	0
2019	7	0
2020	8	0
2021	7	1
2022	9	0
2023	15	0
2024	21	0
2025	19	0
2026	26	0

FIG. 1 — Lineage of K874669, 1987–2026Source: 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.

1 device in this family has a Class I recall. 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 HTN device

#1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.5 · 6 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (137)

See all 137

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

Number	Device	Applicant	Decided	Descendants
K983265	Depuy Ace Composite Locking Nut	Depuy Ace Medical Co.	1998	136

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K983265 (Depuy Ace Medical Co., 1998) has gone furthest, with 136 descendants of its own.

How does its category compare?

All HTN devices

HTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTN

4in 2025

2007high 8 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTN

75in 2025

2007high 130 (2011) · low 75 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HTN

1in 2019

2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HTN

190in 2025

2007high 269 (2024) · low 11 (2008)2025

MAUDE reports naming product code HTN, 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	1	—	0	14
2008	2	—	0	11
2009	3	86	0	22
2010	0	—	0	17
2011	4	130	0	12
2012	0	—	0	69
2013	3	105	1	45
2014	8	98	0	33
2015	2	—	0	35
2016	1	—	0	43
2017	6	88	0	30
2018	2	—	0	48
2019	5	116	1	53
2020	3	87	0	81
2021	2	—	0	149
2022	5	86	0	85
2023	2	—	0	108
2024	6	90	0	269
2025	4	75	0	190
2026	2	—	0	—

https://510kreport.com/device/K874669 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874669: Ace Bone Screw Nut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874669

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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