510(k) · Cleared
ClearedMonticelli Spinelli External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Dec 18, 1986 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.
- Decided
- Dec 18, 1986
- Review
- 38 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 1 citing it directly.
- This deviceK864403 Monticelli Spinelli External Fixation SystemHowmedica Corp. · 1986
- Descendant · cites it directly · 23 of its ownK960297 Mandibular Bone Distractor IIHowmedica Corp. · 1996
- Descendant · 2 generations on · 11 of its ownK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
- Descendant · 2 generations on · 8 of its ownK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
- Descendant · 3 generations on · 7 of its ownK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999
- Descendant · 3 generations on · 6 of its ownK013618 Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K960297Mandibular Bone Distractor IIHowmedica Corp. · 1996 · cites it directly23descendants
- K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997 · 2 generations on11descendants
- K972154Cohen DistractorHowmedica Leibinger, Inc. · 1997 · 2 generations on8descendants
- K990944Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999 · 3 generations on7descendants
- K013618Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864403 | Monticelli Spinelli External Fixation System | Howmedica Corp. | 1986 | — |
| +1 | K960297 | Mandibular Bone Distractor II | Howmedica Corp. | 1996 | — |
| +2 | K972166 | Guerrero - Bell Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| +2 | K972154 | Cohen Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| +3 | K990944 | Osteomed Intraoral Distraction System | Osteomed Corp. | 1999 | — |
| +3 | K013618 | Intraoral Mandibular Distraction System | Osteomed Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960297 | Mandibular Bone Distractor II | 1996 | 23 |
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, K960297 (Howmedica Corp., 1996) has gone furthest, with 23 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/K864403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K864403: Monticelli Spinelli 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/K864403
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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