510(k) · Cleared
ClearedCardinal Health External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinalhealth · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Apr 29, 2015 as substantially equivalent to K140675 (Emerge Medical, Inc., 2014) after a 51-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Apr 29, 2015
- Review
- 51 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082650 (2008). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (1)
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 |
|---|---|---|---|
| * | K140675 | Emerge External Fixation SystemSummary page 5…ization tool to assist with indirect reduction • Unilateral rectilinear bone segment transport or leg lengthening Predicate Device: Emerge External Fixation System (K140675) Performance Data: Testing was performed on the Cardinal Health External Fixation System in accordance with ASTM F2182–11a, Stan… | 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 7 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
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 Cardinal Health External Fixation System is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. The system can be used for: • Stabilization of soft tissues and fractures • Polytrauma/multiple orthopedic trauma • Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures • Arthrodeses and osteotomies with soft tissue problems; failures of total joints •…
Read the full statement (97 words)
The Cardinal Health External Fixation System is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
The system can be used for:
• Stabilization of soft tissues and fractures
• Polytrauma/multiple orthopedic trauma
• Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
• Arthrodeses and osteotomies with soft tissue problems; failures of total joints
• Neutralization of fractures stabilized with limited internal fixation
• Non-unions/septic non-unions
• Intra-operative reductions/stabilization tool to assist with indirect reduction
• Unilateral rectilinear bone segment transport or leg lengthening
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150579: Cardinal Health 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/K150579
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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