510(k) · Cleared
ClearedXtrafix External Fixation System, Xtrafix Small External Fixation System
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 Sep 18, 2014 as substantially equivalent to K113383 (Extraortho, Inc., 2012) and 2 other predicates after an 86-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Sep 18, 2014
- Review
- 86 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K994143 (2000). 12 ancestors in all, the oldest K984357 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
- 4 generations backK091258 Extrafix External Fixation SystemQfx Technologies, Inc. · 2009
- 3 generations backK111155 Xtrafix External Fixation SystemExtraortho, Inc. · 2011
- 2 generations backK113383 Xtrafix External Fixation SystemExtraortho, Inc. · 2012
- 1 generation backK131413 Xtrafix Small External Fixation SystemZimmer, Inc. · 2014
- This deviceK141697 Xtrafix External Fixation System, Xtrafix Small External Fixation…Zimmer, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK152484 FastFrame External Fixation System - Distal RadiusZimmer, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K152484FastFrame External Fixation System - Distal RadiusZimmer, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… | Smith & Nephew, Inc. | 2000 | 19 |
| −4 | K091258 | Extrafix External Fixation System | Qfx Technologies, Inc. | 2009 | — |
| −3 | K111155 | Xtrafix External Fixation System | Extraortho, Inc. | 2011 | — |
| −2 | K113383 | Xtrafix External Fixation System | Extraortho, Inc. | 2012 | — |
| −1 | K131413 | Xtrafix Small External Fixation System | Zimmer, Inc. | 2014 | — |
| 0 (this device) | K141697 | Xtrafix External Fixation System, Xtrafix Small External Fixation System | Zimmer, Inc. | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K113383 | Xtrafix External Fixation SystemSummary page 6…K141697 (pg 2/5) Predicate Device(s): XtraFix Large System -XtraFix External Fixation System, Zimmer, K113383 cleared on 06/26/2012 XtraFix Small System -XtraFix Small E… | 2012 |
| * | K131413 | Xtrafix Small External Fixation SystemSummary page 6…K113383 cleared on 06/26/2012 XtraFix Small System -XtraFix Small External Fixation System, Zimmer, K131413 cleared on 01/28/2014 -TransFx External Fixation System, Zimmer, K990848 cleared on… | 2014 |
| * | K990848 | Transfx Intermediate External Fixation System,Transfx Small External Fixation System…Summary page 6…-XtraFix Small External Fixation System, Zimmer, K131413 cleared on 01/28/2014 -TransFx External Fixation System, Zimmer, K990848 cleared on 5/17/1999 Purpose and Device Description: The purpose of this traditional 510(k) is to se… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152484 | FastFrame External Fixation System - Distal Radius | 2015 | 0 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K152484 (Zimmer, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K113383.
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. 2014, 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 XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. 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…
Read the full statement (202 words)
The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. 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 problems;
-Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
-Stabilization of non-unions; and
-Intraoperative temporary stabilization tool to assist with indirect reduction.
The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. 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 problems;
- Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
- Stabilization of non-unions; and
- Intraoperative temporary stabilization tool to assist with indirect reduction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141697: Xtrafix External Fixation System, Xtrafix Small External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141697
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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