510(k) · Cleared
ClearedHoffmann II External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on May 23, 2000 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 23, 2000
- Review
- 60 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK000957 Hoffmann II External Fixation SystemHowmedica Osteonics Corp. · 2000
- 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
- Descendant · cites it directly · 0 of its ownK022423 External Fixation RingRigid FX Orthopedics, Incorporated · 2002
Most influential descendants
Showing 4 of 4 · 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
- K022423External Fixation RingRigid FX Orthopedics, Incorporated · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000957 | Hoffmann II External Fixation System | Howmedica Osteonics Corp. | 2000 | — |
| +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 | — |
| +1 | K022423 | External Fixation Ring | Rigid FX Orthopedics, Incorporated | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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 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? (4)
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, K021933 (DePuy Orthopaedics, Inc., 2002) has gone furthest, with 2 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/K000957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000957: Hoffmann II External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000957
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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