510(k) · Cleared
ClearedAce-Dupont Composite Rings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Medical Co. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Jan 31, 1996 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jan 31, 1996
- Review
- 68 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK955388 Ace-Dupont Composite RingsAce Medical Co. · 1996
- Descendant · cites it directly · 5 of its ownK083789 Ace Fischer External Fixation SystemDePuy Orthopaedics, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK190486 Pitkar External Fixation SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK021933 Tempfix External Fixation SystemDePuy Orthopaedics, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK202833 Sequel External Fixation DeviceSequel Medical, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K083789Ace Fischer External Fixation SystemDePuy Orthopaedics, Inc. · 2009 · cites it directly5descendants
- K190486Pitkar External Fixation SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2019 · 2 generations on2descendants
- K021933Tempfix External Fixation SystemDePuy Orthopaedics, Inc. · 2002 · cites it directly2descendants
- K202833Sequel External Fixation DeviceSequel Medical, Inc. · 2021 · 3 generations on1descendant
- K253291Excelsior SystemBlue Ocean Global · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955388 | Ace-Dupont Composite Rings | Ace Medical Co. | 1996 | — |
| +1 | K083789 | Ace Fischer External Fixation System | DePuy Orthopaedics, Inc. | 2009 | — |
| +2 | K190486 | Pitkar External Fixation System | S.H.Pitkar Orthotools Pvt., Ltd. | 2019 | — |
| +1 | K021933 | Tempfix External Fixation System | DePuy Orthopaedics, Inc. | 2002 | — |
| +3 | K202833 | Sequel External Fixation Device | Sequel Medical, Inc. | 2021 | — |
| +4 | K253291 | Excelsior System | Blue Ocean Global | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
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 LXT? 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 LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
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? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K083789 (DePuy Orthopaedics, Inc., 2009) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LXT devicesLXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LXT
Too few LXT 510(k)s in any year since 2007 to give a median.
Recalls per year · LXT
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXT
7in 2025
MAUDE reports naming product code LXT, 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 | — | 1 | 26 |
| 2008 | 1 | — | 0 | 58 |
| 2009 | 1 | — | 7 | 41 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 1 | — | 0 | 85 |
| 2012 | 0 | — | 0 | 42 |
| 2013 | 2 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 35 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 66 |
| 2018 | 0 | — | 2 | 73 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K955388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955388: Ace-Dupont Composite Rings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955388
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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