510(k) · Cleared
ClearedPta (Progressive Tibial Alignment)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Medical · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Mar 28, 2006 as substantially equivalent to K032427 (Meridan Medical, 2003) after a 41-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Mar 28, 2006
- Review
- 41 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K803166 (1981). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK803166 Double Ball JointHowmedica Corp. · 1981
- 2 generations backK952730 Hoffmann II External Fixation SystemHowmedica Corp. · 1995
- 1 generation backK032427 Fep Fixation System and Stylo Wrist Fixation SystemMeridan Medical · 2003
- This deviceK060403 Pta (Progressive Tibial Alignment)Meridian Medical · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K803166 | Double Ball Joint | Howmedica Corp. | 1981 | — |
| −2 | K952730 | Hoffmann II External Fixation System | Howmedica Corp. | 1995 | — |
| −1 | K032427 | Fep Fixation System and Stylo Wrist Fixation System | Meridan Medical | 2003 | — |
| 0 (this device) | K060403 | Pta (Progressive Tibial Alignment) | Meridian Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 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.
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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032427 | Fep Fixation System and Stylo Wrist Fixation SystemSummary page 1…The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: K# Device Name Applicant K032427 FEP Meridian Medical REGULATORY SPEcuuIS, INC.… | 2003 |
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 25 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K032427.
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?
The PTA (Progressive Tibial Alignment) external fixation system is a modular system with the components of: joints, bars, clamps or screws. Such components form a device indicated for reconstruction and corrections of bone segments of the human body.
The PTA is for progressive realignment of the knee.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060403: Pta (Progressive Tibial Alignment).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060403
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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