510(k) · Cleared
ClearedF3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hand Biomechanics Lab, Inc. · JEC Component, Traction, Invasive
Cleared on Jan 9, 2008 as substantially equivalent to K970713 (Smith & Nephew, Inc., Orthopaedic Div., 1997) after a 133-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Jan 9, 2008
- Review
- 133 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970713 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK970713 Compass Universal HingeSmith & Nephew, Inc., Orthopaedic Div. · 1997
- This deviceK072432 F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non SterileHand Biomechanics Lab, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK181192 PIP FixHand Biomechanics Lab, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181192PIP FixHand Biomechanics Lab, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970713 | Compass Universal Hinge | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| 0 (this device) | K072432 | F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non Sterile | Hand Biomechanics Lab, Inc. | 2008 | — |
| +1 | K181192 | PIP Fix | Hand Biomechanics Lab, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K970713 | Compass Universal HingeSummary page 1…, Invasive [21 CFR 888.3040, Product Code JEC] Predicate Device: Compass PIP Joint Hinge (Smith Et Nephew, Inc. Orthopedic Div.), K970713 Description of Device: The P3 Fractured Finger Fixator isan external skeletal fixator designed to obtain and m… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181192 | PIP Fix | 2018 | 0 |
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?
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 F3 Fractured Finger Fixator is indicated for the treatment of acute, unstable dorsal fracture-dislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the F3 Fractured Finger Fixator alone is sufficient to obtain and maintain concentric reduction of the fracture-dislocation during bone and soft tissue healing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072432 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072432: F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072432
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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