510(k) · Cleared
ClearedDigiFix Sterile Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Virak Orthopedics, LLC · JEC Component, Traction, Invasive
Cleared on Oct 10, 2019 as substantially equivalent to K132731 (Virak Orthopedic Research, LLC, 2014) after a 31-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Oct 10, 2019
- Review
- 31 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970713 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK970713 Compass Universal HingeSmith & Nephew, Inc., Orthopaedic Div. · 1997
- 3 generations backK980370 Biosymmetric Proximal Interphalangeal Joint FixatorBiomet, Inc. · 1998
- 2 generations backK094043 LigamentotaxorArex USA · 2010
- 1 generation backK132731 Digifix External Fixation SystemVirak Orthopedic Research, LLC · 2014
- This deviceK192465 DigiFix Sterile KitVirak Orthopedics, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970713 | Compass Universal Hinge | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| −3 | K980370 | Biosymmetric Proximal Interphalangeal Joint Fixator | Biomet, Inc. | 1998 | — |
| −2 | K094043 | Ligamentotaxor | Arex USA | 2010 | — |
| −1 | K132731 | Digifix External Fixation System | Virak Orthopedic Research, LLC | 2014 | — |
| 0 (this device) | K192465 | DigiFix Sterile Kit | Virak Orthopedics, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K132731 | Digifix External Fixation SystemSummary page 5…Tab 8-1 K192465 Primary Predicate • K132731 – DigiFix™ External Fixation System Performance Testing: A sterilization validation substantiated a minimum 25 kGy gamma radiati… | 2014 |
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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 DIGIFIXTM External Fixation System is intended to be used in skeletally mature patients in treatment of:
DYNAMIC MODE:
1) complex fracture-dislocations or fracture-subluxation, unstable dislocations, and pilon fractures of the interphalangeal (IP) joint;
2) Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint;
3) Dupuytren’s contracture
STATIC MODE:
1) Fractures of the phalanges and
2) interphalangeal (IP) joint arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192465: DigiFix Sterile Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192465
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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