510(k) · Cleared
ClearedFep Fixation System and Stylo Wrist Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridan Medical · JEC Component, Traction, Invasive
Cleared on Oct 9, 2003 as substantially equivalent to K952730 (Howmedica Corp., 1995) and 1 other predicate after a 64-day review. Its family tree reaches back 2 generations to 1981. 2 later devices descend from it.
- Decided
- Oct 9, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K803166 (1981). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK803166 Double Ball JointHowmedica Corp. · 1981
- 1 generation backK952730 Hoffmann II External Fixation SystemHowmedica Corp. · 1995
- This deviceK032427 Fep Fixation System and Stylo Wrist Fixation SystemMeridan Medical · 2003
- Descendant · cites it directly · 0 of its ownK070016 Blue SharkMeridan Medical · 2007
- Descendant · cites it directly · 0 of its ownK060403 Pta (Progressive Tibial Alignment)Meridian Medical · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K803166 | Double Ball Joint | Howmedica Corp. | 1981 | — |
| −1 | K952730 | Hoffmann II External Fixation System | Howmedica Corp. | 1995 | — |
| 0 (this device) | K032427 | Fep Fixation System and Stylo Wrist Fixation System | Meridan Medical | 2003 | — |
| +1 | K070016 | Blue Shark | Meridan Medical | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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 JEC? 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K952730 | Hoffmann II External Fixation SystemSummary page 1…ich we are claiming equivalence [807.92(a)(3)J : FEP Predicate K# Device Name Manufacturer K952730 Hoffman I I External Fixation System Howmedica Stylo Predicate K# Devi… | 1995 |
| * | K831576 | OrthofixSummary page 1…I I External Fixation System Howmedica Stylo Predicate K# Device Name Manufacturer K831576 Orthofix Orthofix REGULATORY SPECIALISTS, INC.… | 1983 |
What descends from it? (2)
2 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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 14.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070016 (Meridan Medical, 2007) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K952730.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032427: Fep Fixation System and Stylo Wrist 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/K032427
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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