510(k) · Cleared
ClearedSynthes Simple Small External Fixator (Ssef)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Nov 12, 1996 after a 63-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Nov 12, 1996
- Review
- 63 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK963618 Synthes Simple Small External Fixator (Ssef)Synthes (Usa) · 1996
- Descendant · cites it directly · 5 of its ownK984498 Synthes (Usa) Articulating Distal Radius (Adrf) SystemSynthes (Usa) · 1999
- Descendant · 2 generations on · 3 of its ownK012294 Wristore FixatorMillennium Medical Technologies, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK993649 Ebi Xfix DFS Wristfix SystemEbi, L.P. · 1999
- Descendant · 3 generations on · 1 of its ownK042761 Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK012062 PF2Fixano SA · 2001
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K984498Synthes (Usa) Articulating Distal Radius (Adrf) SystemSynthes (Usa) · 1999 · cites it directly5descendants
- K012294Wristore FixatorMillennium Medical Technologies, Inc. · 2002 · 2 generations on3descendants
- K993649Ebi Xfix DFS Wristfix SystemEbi, L.P. · 1999 · cites it directly3descendants
- K042761Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004 · 3 generations on1descendant
- K012062PF2Fixano SA · 2001 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963618 | Synthes Simple Small External Fixator (Ssef) | Synthes (Usa) | 1996 | — |
| +1 | K984498 | Synthes (Usa) Articulating Distal Radius (Adrf) System | Synthes (Usa) | 1999 | — |
| +2 | K012294 | Wristore Fixator | Millennium Medical Technologies, Inc. | 2002 | — |
| +1 | K993649 | Ebi Xfix DFS Wristfix System | Ebi, L.P. | 1999 | — |
| +3 | K042761 | Wristore Distal Radius Fracture Fixator, 4600 Series | Zimmer, Inc. | 2004 | — |
| +2 | K012062 | PF2 | Fixano SA | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | — | EBI’s Orthofix Penning Dynamic Wrist Fixator Named without a submission number |
What descends from it? (10)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984498 (Synthes (Usa), 1999) has gone furthest, with 5 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?
The Synthes SSEF stabilizes fractures of the distal radius.
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/K963618 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963618: Synthes Simple Small External Fixator (Ssef).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963618
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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