510(k) · Cleared
ClearedXtrafix External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Extraortho, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jun 26, 2012 as substantially equivalent to K091258 (Qfx Technologies, Inc., 2009) and 3 other predicates after a 223-day review. Its family tree reaches back 3 generations to 2000. 8 later devices descend from it.
- Decided
- Jun 26, 2012
- Review
- 223 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K994143 (2000). 7 ancestors in all. 8 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
- 2 generations backK091258 Extrafix External Fixation SystemQfx Technologies, Inc. · 2009
- 1 generation backK111155 Xtrafix External Fixation SystemExtraortho, Inc. · 2011
- This deviceK113383 Xtrafix External Fixation SystemExtraortho, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK181528 Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC · 2019
- Descendant · cites it directly · 2 of its ownK131413 Xtrafix Small External Fixation SystemZimmer, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK213874 MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK141697 Xtrafix External Fixation System, Xtrafix Small External Fixation…Zimmer, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK223112 MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC · 2019 · cites it directly2descendants
- K131413Xtrafix Small External Fixation SystemZimmer, Inc. · 2014 · cites it directly2descendants
- K213874MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022 · 2 generations on1descendant
- K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc. · 2014 · cites it directly1descendant
- K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… | Smith & Nephew, Inc. | 2000 | 19 |
| −2 | K091258 | Extrafix External Fixation System | Qfx Technologies, Inc. | 2009 | — |
| −1 | K111155 | Xtrafix External Fixation System | Extraortho, Inc. | 2011 | — |
| 0 (this device) | K113383 | Xtrafix External Fixation System | Extraortho, Inc. | 2012 | — |
| +1 | K181528 | Austin Miller Large External Fixation System | Austin Miller Trauma, LLC | 2019 | — |
| +1 | K131413 | Xtrafix Small External Fixation System | Zimmer, Inc. | 2014 | — |
| +2 | K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | 2022 | — |
| +1 | K141697 | Xtrafix External Fixation System, Xtrafix Small External Fixation System | Zimmer, Inc. | 2014 | — |
| +3 | K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 21.4 · 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? (4)
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 |
|---|---|---|---|
| * | K091258 | Extrafix External Fixation SystemSummary page 1…Predicate Devices: The XtraFix External Fixation System Line Additions are similar to several predicates including the following: *XtraFix External Fixation System (K(091258 and K(111155); YKI' ' 33 XtraFix External Fixation System Line Additions… | 2009 |
| * | K111155 | Xtrafix External Fixation SystemSummary page 1…ices: The XtraFix External Fixation System Line Additions are similar to several predicates including the following: *XtraFix External Fixation System (K(091258 and K(111155); YKI' ' 33 XtraFix External Fixation System Line Additions… | 2011 |
| * | K031428 | Synthes (Usa) Large External Fixation Clamps-MR SafeSummary page 2…YKI' ' 33 XtraFix External Fixation System Line Additions 510(k) Summary *Synthes Large External Fixation Clamps- MR S(K(031428); and *Smith & Nephew Jet-X Unilateral Fixator (K(994143). Technological Characteristics The principles of operation of the Xt… | 2003 |
| * | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…Summary page 2…e Additions 510(k) Summary *Synthes Large External Fixation Clamps- MR S(K(031428); and *Smith & Nephew Jet-X Unilateral Fixator (K(994143). Technological Characteristics The principles of operation of the XtraFix External Fixation System Line Additions are the same… | 2000 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181528 | Austin Miller Large External Fixation System | 2019 | 2 |
| K131413 | Xtrafix Small External Fixation System | 2014 | 2 |
| K141697 | Xtrafix External Fixation System, Xtrafix Small External Fixation System | 2014 | 1 |
| K152755 | FastFrame External Fixation System-Ankle Spanning | 2015 | 0 |
| K151992 | FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System -… | 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 12 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K181528 (Austin Miller Trauma, LLC, 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K091258.
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. 2012, 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: o Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; o Arthrodesis and…
Read the full statement (103 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:
o Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
o Arthrodesis and osteotomies with associated soft tissue problems;
o Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
o Stabilization of non-unions; and
o Intraoperative temporary stabilization tool to assist with indirect reduction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113383: Xtrafix External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113383
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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