510(k) · Cleared
ClearedFastFrame External Fixation System - Distal Radius
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Dec 4, 2015 as substantially equivalent to K131413 (Zimmer, Inc., 2014) and 1 other predicate after a 95-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Dec 4, 2015
- Review
- 95 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K994143 (2000). 13 ancestors in all, the oldest K984357 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
- 5 generations backK091258 Extrafix External Fixation SystemQfx Technologies, Inc. · 2009
- 4 generations backK111155 Xtrafix External Fixation SystemExtraortho, Inc. · 2011
- 3 generations backK113383 Xtrafix External Fixation SystemExtraortho, Inc. · 2012
- 2 generations backK131413 Xtrafix Small External Fixation SystemZimmer, Inc. · 2014
- 1 generation backK141697 Xtrafix External Fixation System, Xtrafix Small External Fixation…Zimmer, Inc. · 2014
- This deviceK152484 FastFrame External Fixation System - Distal RadiusZimmer, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… | Smith & Nephew, Inc. | 2000 | 19 |
| −5 | K091258 | Extrafix External Fixation System | Qfx Technologies, Inc. | 2009 | — |
| −4 | K111155 | Xtrafix External Fixation System | Extraortho, Inc. | 2011 | — |
| −3 | K113383 | Xtrafix External Fixation System | Extraortho, Inc. | 2012 | — |
| −2 | K131413 | Xtrafix Small External Fixation System | Zimmer, Inc. | 2014 | — |
| −1 | K141697 | Xtrafix External Fixation System, Xtrafix Small External Fixation System | Zimmer, Inc. | 2014 | — |
| 0 (this device) | K152484 | FastFrame External Fixation System - Distal Radius | Zimmer, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 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 |
|---|---|---|---|
| * | K131413 | Xtrafix Small External Fixation SystemSummary page 4…on Panel: Orthopedics/87 Predicate Device(s): -XtraFix Small External Fixation System by Zimmer Inc. K131413, cleared 28-Jan-2014 -XtraFix Small External Fixation System by Zimmer Inc.… | 2014 |
| * | K141697 | Xtrafix External Fixation System, Xtrafix Small External Fixation SystemSummary page 4…K131413, cleared 28-Jan-2014 -XtraFix Small External Fixation System by Zimmer Inc. K141697, cleared 18-Sep-2014 Purpose and The purpose of this 510(k) is to obtain marketing Device Description:… | 2014 |
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 15 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K131413.
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. 2015, this device’s year, is highlighted.
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 FastFrame External Fixation System - Distal Radius is indicated for use in treatment of appropriately sized long bone (wrist and hand) fractures. Specifically, the system is intended for:
-Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
- Arthrodesis and osteotomies with associated soft tissue;
- Stabilization of non-unions; and
- Intraoperative temporary stabilization to assist with indirect reduction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152484: FastFrame External Fixation System - Distal Radius.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152484
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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