510(k) · Cleared
ClearedWristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNS
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 Jun 10, 2003 as substantially equivalent to K984442 (Hand Biomechanics Lab, Inc., 1999) after a 111-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jun 10, 2003
- Review
- 111 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K842493 (1985). No later device cites it as a predicate yet.
- Root · 2 generations backK842493 Agee External FixatorThe Hand Biomechanics Research Laboratory · 1985
- 1 generation backK984442 Agee-Wristjack Fracture Reaction System (Sterile Version), Model…Hand Biomechanics Lab, Inc. · 1999 · Recalled
- This deviceK030519 Wristjack System (Remanufactured), Sterile and Non-Sterile, Models…Hand Biomechanics Lab, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842493 | Agee External Fixator | The Hand Biomechanics Research Laboratory | 1985 | — |
| −1 | K984442 | Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147 | Hand Biomechanics Lab, Inc. | 1999 | 1 |
| 0 (this device) | K030519 | Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS… | Hand Biomechanics Lab, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K984442 | Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147Summary page 1…ards: No performance standards exist for this device. Predicate Device: Agee WristJack Fracture Reduction System (sterile), item No. CFD-147, K984442 Description of Device: The WristJack System i s an external fixation system used for reduction and fixation… | 1999 |
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 18 years and passes through 2 companies; a new generation was cleared every 14.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K984442.
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?
Fracture reduction and external fixation for treatment of distal radius fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030519: Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030519
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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