510(k) · Cleared
ClearedPara-Fix External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Paradigm Biomedical · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Sep 22, 2023 as substantially equivalent to K051306 (Howmedica Osteonics Corp., 2005) and 1 other predicate after a 256-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Sep 22, 2023
- Review
- 256 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K051306 (2005). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051306 | Hoffmann II Mri External Fixation System | Howmedica Osteonics Corp. | 2005 | — |
| −1 | K111786 | Hoffmann 3 Modular External Fixation System | Stryker Corp. | 2012 | — |
| 0 (this device) | K230067 | Para-Fix External Fixation System | New Paradigm Biomedical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 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.
Planning a device in LXT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K051306.
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. 2023, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Para-Fix External Fixation System is intended to provide stabilization of open and/or unstable fractures and where tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
The specific indications for the Para-Fix External Fixation System include:
* Bone fracture fixation
* Osteotomy
* Arthrodesis
* Correction of deformity
* Revision procedure where other treatments or devices have been unsuccessful
* Bone reconstruction procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230067: Para-Fix External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230067
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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