510(k) · Cleared
ClearedAce Unilateral Fixator II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Orthopedic Manufacturing Co. · JEC Component, Traction, Invasive
Cleared on Feb 22, 1994 after a 64-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 22, 1994
- Review
- 64 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK936045 Ace Unilateral Fixator IIAce Orthopedic Manufacturing Co. · 1994
- Descendant · cites it directly · 2 of its ownK021933 Tempfix External Fixation SystemDePuy Orthopaedics, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK052918 Reprocessed External Fixation DevicesAlliance Medical Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK043113 Tempfix External Fixation System, MR SafeDePuy Orthopaedics, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K021933Tempfix External Fixation SystemDePuy Orthopaedics, Inc. · 2002 · cites it directly2descendants
- K052918Reprocessed External Fixation DevicesAlliance Medical Corp. · 2006 · 2 generations on0descendants
- K043113Tempfix External Fixation System, MR SafeDePuy Orthopaedics, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936045 | Ace Unilateral Fixator II | Ace Orthopedic Manufacturing Co. | 1994 | — |
| +1 | K021933 | Tempfix External Fixation System | DePuy Orthopaedics, Inc. | 2002 | — |
| +2 | K052918 | Reprocessed External Fixation Devices | Alliance Medical Corp. | 2006 | — |
| +2 | K043113 | Tempfix External Fixation System, MR Safe | DePuy Orthopaedics, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 JEC? 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021933 | Tempfix External Fixation System | 2002 | 2 |
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, K021933 (DePuy Orthopaedics, Inc., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K936045 · printed Nov 5, 2026
Cite this page
510(k) Report. “K936045: Ace Unilateral Fixator II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K936045
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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