510(k) · Cleared
Recalled · Class II · 2025D.N.E. External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dne, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Feb 16, 2016 as substantially equivalent to K113106 (Dne, LLC, 2012) after a 250-day review. Its family tree reaches back 3 generations to 1994. It has been recalled once.
- Decided
- Feb 16, 2016
- Review
- 250 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941048 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK941048 True/Lok Monolateral/Bilateral FixatorApplied Osteo Systems, Inc. · 1994 · Recalled
- 2 generations backK052005 R&R External Fixation SystemR&R Medical, Inc. · 2005
- 1 generation backK113106 Dne External Fixation SystemDne, LLC · 2012
- This deviceK151580 D.N.E. External Fixation SystemDne, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941048 | True/Lok Monolateral/Bilateral Fixator | Applied Osteo Systems, Inc. | 1994 | 1 |
| −2 | K052005 | R&R External Fixation System | R&R Medical, Inc. | 2005 | — |
| −1 | K113106 | Dne External Fixation System | Dne, LLC | 2012 | — |
| 0 (this device) | K151580 | D.N.E. External Fixation System | Dne, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 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? (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 |
|---|---|---|---|
| * | K113106 | Dne External Fixation SystemSummary page 5…Frame Classification: Class II Regulation Number: 21 CFR 888.3030 Panel: Orthopedic Product Code: KTT Primary Predicate: K113106 – D.N.E. External Fixation System Device Description: The D.N.E. External Fixation System assembly consists of three basic ty… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 2, 2025 | Class II | Z-2513-2025 | Process control | Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K113106.
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. 2016, 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 D.N.E. Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The D.N.E. Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151580: D.N.E. 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/K151580
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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