510(k) · Cleared
ClearedJet-X Bar System Clamps, Bars and Posts-MR Safe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Mar 7, 2008 after a 211-day review. The FDA summary names no predicate by number. 77 later devices descend from it.
- Decided
- Mar 7, 2008
- Review
- 211 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
77 later devices descend from it, 12 citing it directly.
- This deviceK072212 Jet-X Bar System Clamps, Bars and Posts-MR SafeSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 51 of its ownK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 32 of its ownK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- Descendant · 3 generations on · 26 of its ownK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- Descendant · 4 generations on · 19 of its ownK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- Descendant · 2 generations on · 18 of its ownK110069 Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · cites it directly51descendants
- K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014 · 2 generations on32descendants
- K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014 · 3 generations on26descendants
- K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015 · 4 generations on19descendants
- K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072212 | Jet-X Bar System Clamps, Bars and Posts-MR Safe | Smith & Nephew, Inc. | 2008 | — |
| +1 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| +2 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| +3 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
| +4 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015 | — |
| +2 | K110069 | Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software | Smith & Nephew, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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?
The FDA summary names no predicate by number.
What descends from it? (77)
See all 7712 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093047 | Smith & Nephew Circular Fixation System | 2010 | 51 |
| K090926 | Smith & Nephew Rail System | 2009 | 10 |
| K111155 | Xtrafix External Fixation System | 2011 | 9 |
| K113770 | Orthofix Galaxy Fixation System | 2012 | 6 |
| K120871 | Smith & Nephew, Inc. External Fixation System Instrumentation | 2012 | 6 |
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV… | 2020 | 5 |
| K181528 | Austin Miller Large External Fixation System | 2019 | 2 |
| K213874 | MAVERICK External Fixation System | 2022 | 1 |
| K132731 | Digifix External Fixation System | 2014 | 1 |
| K180580 | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices | 2018 | 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?
- Of its descendants, K093047 (Smith & Nephew, Inc., 2010) has gone furthest, with 51 descendants of its own.
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. 2008, 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?
Jet-X Bar External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis of long bones; limb lengthening by…
Read the full statement (120 words)
Jet-X Bar External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; infected fractures or non-unions; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius.
Jet-X® Bar System Clamps, Bars and Posts - MR Conditional components are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072212 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072212
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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