510(k) · Cleared
ClearedAgee-Wristjack Pre-Drill Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hand Biomechanics Lab, Inc. · HTW Bit, Drill
Cleared on Dec 22, 1994 after a 184-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 22, 1994
- Review
- 184 days
- Class
- Class I
- Product code
- HTW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK942906 Agee-Wristjack Pre-Drill KitHand Biomechanics Lab, Inc. · 1994
- Descendant · cites it directly · 5 of its ownK984498 Synthes (Usa) Articulating Distal Radius (Adrf) SystemSynthes (Usa) · 1999
- Descendant · 2 generations on · 3 of its ownK012294 Wristore FixatorMillennium Medical Technologies, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK042761 Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK101338 Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011
- Descendant · 4 generations on · 0 of its ownK052498 Fragment Specific FixatorDavid J. Slutsky MD · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K984498Synthes (Usa) Articulating Distal Radius (Adrf) SystemSynthes (Usa) · 1999 · cites it directly5descendants
- K012294Wristore FixatorMillennium Medical Technologies, Inc. · 2002 · 2 generations on3descendants
- K042761Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004 · 3 generations on1descendant
- K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011 · 3 generations on0descendants
- K052498Fragment Specific FixatorDavid J. Slutsky MD · 2005 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942906 | Agee-Wristjack Pre-Drill Kit | Hand Biomechanics Lab, Inc. | 1994 | — |
| +1 | K984498 | Synthes (Usa) Articulating Distal Radius (Adrf) System | Synthes (Usa) | 1999 | — |
| +2 | K012294 | Wristore Fixator | Millennium Medical Technologies, Inc. | 2002 | — |
| +3 | K042761 | Wristore Distal Radius Fracture Fixator, 4600 Series | Zimmer, Inc. | 2004 | — |
| +3 | K101338 | Newfix External Fixation System | Technologia Y Diseno Industrial, S.A DE C.V | 2011 | — |
| +4 | K052498 | Fragment Specific Fixator | David J. Slutsky MD | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984498 | Synthes (Usa) Articulating Distal Radius (Adrf) System | 1999 | 5 |
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?
- Of its descendants, K984498 (Synthes (Usa), 1999) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HTW devicesHTW Bit, Drill: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTW
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HTW
Too few HTW 510(k)s in any year since 2007 to give a median.
Recalls per year · HTW
4in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTW
1,507in 2025
MAUDE reports naming product code HTW, 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 | 0 | — | 0 | 146 |
| 2008 | 0 | — | 5 | 216 |
| 2009 | 0 | — | 1 | 256 |
| 2010 | 0 | — | 0 | 270 |
| 2011 | 0 | — | 2 | 225 |
| 2012 | 0 | — | 5 | 256 |
| 2013 | 0 | — | 1 | 519 |
| 2014 | 0 | — | 0 | 409 |
| 2015 | 0 | — | 0 | 400 |
| 2016 | 1 | — | 0 | 595 |
| 2017 | 0 | — | 1 | 1,129 |
| 2018 | 0 | — | 0 | 1,240 |
| 2019 | 0 | — | 2 | 1,212 |
| 2020 | 0 | — | 1 | 1,245 |
| 2021 | 0 | — | 4 | 1,569 |
| 2022 | 0 | — | 0 | 1,519 |
| 2023 | 0 | — | 0 | 1,772 |
| 2024 | 0 | — | 0 | 1,422 |
| 2025 | 0 | — | 0 | 1,507 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K942906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K942906: Agee-Wristjack Pre-Drill Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K942906
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026