510(k) · Cleared
Recalled · Class II · 2016Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147
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 Feb 12, 1999 as substantially equivalent to K842493 (The Hand Biomechanics Research Laboratory, 1985) after a 60-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 12, 1999
- Review
- 60 days
- Class
- Class II
- Product code
- JEC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K842493 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK842493 Agee External FixatorThe Hand Biomechanics Research Laboratory · 1985
- This deviceK984442 Agee-Wristjack Fracture Reaction System (Sterile Version), Model…Hand Biomechanics Lab, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK033112 Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models…Hand Biomechanics Lab, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK030519 Wristjack System (Remanufactured), Sterile and Non-Sterile, Models…Hand Biomechanics Lab, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See all- K033112Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NSHand Biomechanics Lab, Inc. · 2003 · cites it directly0descendants
- K030519Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNSHand Biomechanics Lab, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842493 | Agee External Fixator | The Hand Biomechanics Research Laboratory | 1985 | — |
| 0 (this device) | K984442 | Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147 | Hand Biomechanics Lab, Inc. | 1999 | — |
| +1 | K033112 | Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347… | Hand Biomechanics Lab, Inc. | 2003 | — |
| +1 | K030519 | Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS… | Hand Biomechanics Lab, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 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 |
|---|---|---|---|
| * | K842493 | Agee External FixatorSummary page 1…erformance Standards: No performance standards exist for this device. Predicate Device: Agee-WristJack Fracture Reduction System (non-sterile version), Item No. CFD-47, K842493 Description of Device: The Agee-WristJack System is an external fixation system used for reduction and fixation of distal radius… | 1985 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2016 | Class II | Z-0136-2017 | Under Investigation by firm | A number of Agee WristJack Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K033112 (Hand Biomechanics Lab, Inc., 2003) has gone furthest, with 0 descendants of its own.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984442: Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984442
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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