510(k) · Cleared
ClearedJet-X Bar Clamps and Pin Clamps-Non-Magnetic/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 Sep 24, 2004 after a 29-day review. The FDA summary names no predicate by number. 8 later devices descend from it.
- Decided
- Sep 24, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK042312 Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR SafeSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020
- Descendant · 2 generations on · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 2026
- Descendant · 2 generations on · 0 of its ownK253202 Hoffmann LRF SystemStryker GmbH · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly6descendants
- K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew · 2020 · cites it directly5descendants
- K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 2 generations on1descendant
- K253291Excelsior SystemBlue Ocean Global · 2026 · 2 generations on0descendants
- K253202Hoffmann LRF SystemStryker GmbH · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042312 | Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe | Smith & Nephew, Inc. | 2004 | — |
| +1 | K120871 | Smith & Nephew, Inc. External Fixation System Instrumentation | Smith & Nephew, Inc. | 2012 | — |
| +1 | K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator… | Smith & Nephew | 2020 | — |
| +2 | K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025 | — |
| +2 | K253291 | Excelsior System | Blue Ocean Global | 2026 | — |
| +2 | K253202 | Hoffmann LRF System | Stryker GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K120871 (Smith & Nephew, Inc., 2012) has gone furthest, with 6 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.
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 injoint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis of long bones; limb lengthening by epiphysea[…
Read the full statement (118 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 injoint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis of long bones; limb lengthening by epiphysea[ 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 Clamp and Pin Clamp - Non-magnetic/MR Safe components are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042312: Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042312
Report an extraction error
Are you the manufacturer?
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