510(k) · Cleared
ClearedDepuy Ace Composite Locking Nut
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ace Medical Co. · HTN Washer, Bolt Nut
Cleared on Oct 26, 1998 as substantially equivalent to K874669 (Buckman Co., Inc., 1987) and 1 other predicate after a 39-day review. Its family tree reaches back 1 generation to 1987. 1 of the 139 devices in its family, counting itself, has a Class I recall. 136 later devices descend from it.
- Decided
- Oct 26, 1998
- Review
- 39 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K874669 (1987). 2 ancestors in all. 136 later devices descend from it, 1 citing it directly. 1 of the 139 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK874669 Ace Bone Screw NutBuckman Co., Inc. · 1987
- This deviceK983265 Depuy Ace Composite Locking NutDepuy Ace Medical Co. · 1998
- Descendant · cites it directly · 135 of its ownK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 3 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
- Descendant · 4 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 5 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
Showing 5 of 136 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 136 · See all- K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · cites it directly135descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 3 generations on74descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 4 generations on69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 5 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874669 | Ace Bone Screw Nut | Buckman Co., Inc. | 1987 | — |
| 0 (this device) | K983265 | Depuy Ace Composite Locking Nut | Depuy Ace Medical Co. | 1998 | — |
| +1 | K112885 | Zimmer Plates and Screws System Screws Only | Zimmer, Inc. | 2011 | 15 |
| +2 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +3 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
| +4 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +5 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
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.
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 16.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K874669 | Ace Bone Screw NutSummary page 1…te the load against the bone. 3 The DePuy ACE Composite Locking Nut is a combination of the DePuy ACE Nut for Cortical Bone Screws which received clearance under 510(k) K874669 and the DePuy ACE Washer which received clearance under 510(k) K895107. The function of the DePuy ACE Composite Locking Nut is a… | 1987 |
| * | K895107 | Ace Orthopaedic WashersSummary page 1…a combination of the DePuy ACE Nut for Cortical Bone Screws which received clearance under 510(k) K874669 and the DePuy ACE Washer which received clearance under 510(k) K895107. The function of the DePuy ACE Composite Locking Nut is a combination of both the nut and the washer: to act as the mating part t… | 1989 |
What descends from it? (136)
See all 1361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112885 | Zimmer Plates and Screws System Screws Only | 2011 | 135 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K112885 (Zimmer, Inc., 2011) has gone furthest, with 135 descendants of its own.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 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 | — |
What is it indicated for?
The DePuy ACE Composite Locking Nut is used as follows:
Cortical bone screws (alone)
Intramedullary nails as locking bolts
Screws with plates
Where extra purchase in far cortex is required
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983265: Depuy Ace Composite Locking Nut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983265
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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