510(k) · Cleared
Recalled · 2009Transfx External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immedica, Inc. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Mar 4, 1999 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it. It has been recalled 7 times.
- Decided
- Mar 4, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- LXT
- Recalls
- 7
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK984357 Transfx External Fixation SystemImmedica, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK131413 Xtrafix Small External Fixation SystemZimmer, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK110965 Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011
- Descendant · cites it directly · 2 of its ownK021933 Tempfix External Fixation SystemDePuy Orthopaedics, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK141697 Xtrafix External Fixation System, Xtrafix Small External Fixation…Zimmer, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK213905 ONX Large External Fixation SystemOrthonovis, Inc. · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K131413Xtrafix Small External Fixation SystemZimmer, Inc. · 2014 · cites it directly2descendants
- K110965Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011 · cites it directly2descendants
- K021933Tempfix External Fixation SystemDePuy Orthopaedics, Inc. · 2002 · cites it directly2descendants
- K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc. · 2014 · 2 generations on1descendant
- K213905ONX Large External Fixation SystemOrthonovis, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984357 | Transfx External Fixation System | Immedica, Inc. | 1999 | — |
| +1 | K131413 | Xtrafix Small External Fixation System | Zimmer, Inc. | 2014 | — |
| +1 | K110965 | Renovis T 710 Large External Fixation System | Renovis Surgical Technologies, LLC | 2011 | — |
| +1 | K021933 | Tempfix External Fixation System | DePuy Orthopaedics, Inc. | 2002 | — |
| +2 | K141697 | Xtrafix External Fixation System, Xtrafix Small External Fixation System | Zimmer, Inc. | 2014 | — |
| +2 | K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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.
Top candidate predicates for a new LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.4 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2009 | Not classified | Z-1533-2009 | Process control | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
| May 1, 2009 | Not classified | Z-1532-2009 | Process control | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
| May 1, 2009 | Not classified | Z-1538-2009 | Process control | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
| May 1, 2009 | Not classified | Z-1534-2009 | Process control | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
| May 1, 2009 | Not classified | Z-1535-2009 | Process control | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
| May 1, 2009 | Not classified | Z-1536-2009 | Process control | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
| May 1, 2009 | Not classified | Z-1537-2009 | Process control | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K131413 (Zimmer, Inc., 2014) 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 | — |
What is it indicated for?
Fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and peri-articular fracture -
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984357 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984357: Transfx 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/K984357
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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