510(k) · Cleared
ClearedWristore Fixator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millennium Medical Technologies, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Mar 4, 2002 as substantially equivalent to K003397 (DePuy Orthopaedics, Inc., 2001) and 1 other predicate after a 227-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Mar 4, 2002
- Review
- 227 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K942906 (1994). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK942906 Agee-Wristjack Pre-Drill KitHand Biomechanics Lab, Inc. · 1994
- 1 generation backK984498 Synthes (Usa) Articulating Distal Radius (Adrf) SystemSynthes (Usa) · 1999
- This deviceK012294 Wristore FixatorMillennium Medical Technologies, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK042761 Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK101338 Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011
- Descendant · 2 generations on · 0 of its ownK052498 Fragment Specific FixatorDavid J. Slutsky MD · 2005
Most influential descendants
Showing 3 of 3 · See all- K042761Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004 · cites it directly1descendant
- K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011 · cites it directly0descendants
- K052498Fragment Specific FixatorDavid J. Slutsky MD · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942906 | Agee-Wristjack Pre-Drill Kit | Hand Biomechanics Lab, Inc. | 1994 | — |
| −1 | K984498 | Synthes (Usa) Articulating Distal Radius (Adrf) System | Synthes (Usa) | 1999 | — |
| 0 (this device) | K012294 | Wristore Fixator | Millennium Medical Technologies, Inc. | 2002 | — |
| +1 | K042761 | Wristore Distal Radius Fracture Fixator, 4600 Series | Zimmer, Inc. | 2004 | — |
| +1 | K101338 | Newfix External Fixation System | Technologia Y Diseno Industrial, S.A DE C.V | 2011 | — |
| +2 | K052498 | Fragment Specific Fixator | David J. Slutsky MD | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.4 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K003397 | Colles C Series Frame Sterile PackSummary page 1…istore Fixator is substantially equivalent to the following legally marketed upper extremity external fixators marketed by DePuy, Inc and Synthes, Inc. respectively. e K003397, Colles C Series Frame Sterile Pack. K984498, Articulating Distal Radius Fixator. Both referericed equivalent fixators are legal… | 2001 |
| * | K984498 | Synthes (Usa) Articulating Distal Radius (Adrf) SystemSummary page 1…the following legally marketed upper extremity external fixators marketed by DePuy, Inc and Synthes, Inc. respectively. e K003397, Colles C Series Frame Sterile Pack. K984498, Articulating Distal Radius Fixator. Both referericed equivalent fixators are legally marketed. Both fixators have the sariie in… | 1999 |
What descends from it? (3)
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)
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 8 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K042761 (Zimmer, Inc., 2004) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K003397.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The Wristore Fixator is intended to provide external fixation of the upper extremity. External fixation devices allow for three plane (axial, AP & medio/lateral) control over fractures and bone segments.
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/K012294 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012294: Wristore Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012294
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026