510(k) · Cleared
ClearedCarbon Fiber Composite Circular Fixation (Cirfix) Device (Half Ring)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyberorthology, Inc. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Sep 22, 2003 as substantially equivalent to K962808 (Smith & Nephew Richards, Inc., 1996) and 1 other predicate after a 68-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Sep 22, 2003
- Review
- 68 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K870961 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK870961 Richards External Fixation SystemRichards Medical Co., Inc. · 1987
- This deviceK032169 Carbon Fiber Composite Circular Fixation (Cirfix) Device (Half Ring)Cyberorthology, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870961 | Richards External Fixation System | Richards Medical Co., Inc. | 1987 | — |
| 0 (this device) | K032169 | Carbon Fiber Composite Circular Fixation (Cirfix) Device (Half Ring) | Cyberorthology, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 6.4 · 2 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962808 | Ilizarov External Fixation SystemSummary page 1…COMBINATION, MULTIPLE COMPONENT Classification Product Code: KTT Predicate Device: Ilizarov External Fixation System K962808 External Fixation System K870961 Intended Use: Open and closed fracture fixat… | 1996 |
| * | K870961 | Richards External Fixation SystemSummary page 1…KTT Predicate Device: Ilizarov External Fixation System K962808 External Fixation System K870961 Intended Use: Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotat… | 1987 |
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?
- None of the 2 ancestors has a recall.
- 7 other devices also cite its predicate K962808.
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?
Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K032169 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032169: Carbon Fiber Composite Circular Fixation (Cirfix) Device (Half Ring).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032169
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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