510(k) · Cleared
ClearedFragment Specific Fixator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
David J. Slutsky MD · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Oct 17, 2005 as substantially equivalent to K042761 (Zimmer, Inc., 2004) and 1 other predicate after a 35-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 17, 2005
- Review
- 35 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K942906 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK942906 Agee-Wristjack Pre-Drill KitHand Biomechanics Lab, Inc. · 1994
- 3 generations backK984498 Synthes (Usa) Articulating Distal Radius (Adrf) SystemSynthes (Usa) · 1999
- 2 generations backK012294 Wristore FixatorMillennium Medical Technologies, Inc. · 2002
- 1 generation backK042761 Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004
- This deviceK052498 Fragment Specific FixatorDavid J. Slutsky MD · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942906 | Agee-Wristjack Pre-Drill Kit | Hand Biomechanics Lab, Inc. | 1994 | — |
| −3 | K984498 | Synthes (Usa) Articulating Distal Radius (Adrf) System | Synthes (Usa) | 1999 | — |
| −2 | K012294 | Wristore Fixator | Millennium Medical Technologies, Inc. | 2002 | — |
| −1 | K042761 | Wristore Distal Radius Fracture Fixator, 4600 Series | Zimmer, Inc. | 2004 | — |
| 0 (this device) | 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 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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 21.3 · 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 |
|---|---|---|---|
| * | K042761 | Wristore Distal Radius Fracture Fixator, 4600 SeriesSummary page 1…R 888.3040, 3030 Predicate Devices: Millennium Medical Technologies, Inc., Wristore Distal Radius Fracture Fixator, K042761, cleared November 17, 2004. Howmedica Osteonics Corp., H… | 2004 |
| * | K050048 | Hoffman II Micro External Fixation SystemSummary page 1…November 17, 2004. Howmedica Osteonics Corp., Hoffmann 11Micro External Fixation System, K050048, cleared March 4, 2005. Device Description: The Fragment Specific Fixator is… | 2005 |
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 11 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
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 Fragment Specific fixator is intended for use in adult male and females from skeletal maturity to the geriatric population who have sustained an unstable extra-articular distal radius fracture that cannot be managed by casting, or a 3- or 4-part intra-articular fracture provided the medial fragment is large enough for the insertion of 2 separate 2.5mm - 3.0mm threaded cortical pins. The device can be used in a nonjoint bridging configuration which allows for immediate wrist motion during the fracture healing period of 6-8 weeks. It may alternatively be used in a joint bridging manner to provide ligamentotaxis to obtain and maintain the fracture reduction during the healing period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052498: Fragment Specific Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052498
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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