510(k) · Cleared
ClearedNewfix External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tecnologia Y Diseno Industrial, S.A DE C.V · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Apr 19, 2013 as substantially equivalent to K955848 (Orthofix, Inc., 1996) and 11 other predicates after a 268-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Apr 19, 2013
- Review
- 268 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 6 generations to K993886 (1999). 37 ancestors in all, the oldest K831576 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK993886 Ebi Xfix Vision Fixation SystemEbi, L.P. · 1999
- 5 generations backK011711 Modification to Ebi Efix Vision Fixation SystemEbi, L.P. · 2001
- 4 generations backK014194 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002
- 3 generations backK033635 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2003
- 2 generations backK040833 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2004
- 1 generation backK081244 Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · Recalled
- This deviceK122210 Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K993886 | Ebi Xfix Vision Fixation System | Ebi, L.P. | 1999 | — |
| −5 | K011711 | Modification to Ebi Efix Vision Fixation System | Ebi, L.P. | 2001 | — |
| −4 | K014194 | Modification to Ebi Xfix Vision Fixation System | Ebi, L.P. | 2002 | — |
| −3 | K033635 | Modification to Ebi Xfix Vision Fixation System | Ebi, L.P. | 2003 | — |
| −2 | K040833 | Modification to Ebi Xfix Vision Fixation System | Ebi, L.P. | 2004 | — |
| −1 | K081244 | Lower Extremity External Fixation - Expanded Indications | Biomet Trauma | 2008 | 1 |
| 0 (this device) | K122210 | Newfix External Fixation System | Tecnologia Y Diseno Industrial, S.A DE C.V | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 21.3 · 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? (12)
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 |
|---|---|---|---|
| * | K955848 | Orthofix ModulsystemSummary page 2…Predicate component - auatrradPoutProduct Radiolucent Wrist Fixator, Ankle Orthofix Dynamic Axial Fixation k955848, K(013540. Clamp, Pelvic Fixator (T Clamp for System (primary) K(012024, K(031919, Pelvic F… | 1996 |
| * | K013540 | Ebi Xfix Access Pelvic FixatorSummary page 2…e component - auatrradPoutProduct Radiolucent Wrist Fixator, Ankle Orthofix Dynamic Axial Fixation k955848, K(013540. Clamp, Pelvic Fixator (T Clamp for System (primary) K(012024, K(031919, Pelvic Fixator and… | 2001 |
| * | K012024 | Ebi Xfix DFS SystemSummary page 2…e Orthofix Dynamic Axial Fixation k955848, K(013540. Clamp, Pelvic Fixator (T Clamp for System (primary) K(012024, K(031919, Pelvic Fixator and Straight Clamp for EBI® XFIX® DFS and EBI®D XFIX® K(953406 K(040935 Pelvic Fix… | 2001 |
| * | K031919 | Ebi Xfix DFS SystemSummary page 2…Orthofix Dynamic Axial Fixation k955848, K(013540. Clamp, Pelvic Fixator (T Clamp for System (primary) K(012024, K(031919, Pelvic Fixator and Straight Clamp for EBI® XFIX® DFS and EBI®D XFIX® K(953406 K(040935 Pelvic Fixator)… | 2003 |
| * | K953406 | Ebi X Fix Dynafix System (DFS)Summary page 2…or System (primary) K(012024, K(031919, Pelvic Fixator and Straight Clamp for EBI® XFIX® DFS and EBI®D XFIX® K(953406 K(040935 Pelvic Fixator) (Access Pelvic Fixator) Lengthener(Elongator) Systems EBl® (Bio… | 1995 |
| * | K040935 | Ebi Xfix DFS SystemSummary page 2…System (primary) K(012024, K(031919, Pelvic Fixator and Straight Clamp for EBI® XFIX® DFS and EBI®D XFIX® K(953406 K(040935 Pelvic Fixator) (Access Pelvic Fixator) Lengthener(Elongator) Systems EBl® (Biomretl® Ca… | 2004 |
| * | K991941 | Ebi Xfix DFS Rail SystemSummary page 2…K(040935 Pelvic Fixator) (Access Pelvic Fixator) Lengthener(Elongator) Systems EBl® (Biomretl® Carbon Rail Deformity K(991941, K000083, System) 1(010437,1(021031,… | 1999 |
| * | K000083 | Ebi Xfix DFS Rail SystemSummary page 2…Pelvic Fixator) (Access Pelvic Fixator) Lengthener(Elongator) Systems EBl® (Biomretl® Carbon Rail Deformity K(991941, K000083, System) 1(010437,1(021031,… | 2000 |
| * | K010437 | Modification to Ebi Xfix DFS Rail SystemSummary page 2…EBl® (Biomretl® Carbon Rail Deformity K(991941, K000083, System) 1(010437,1(021031, Orthofix Adult Limb Reconstruction 1(033635, k081244… | 2001 |
| * | K021031 | Ebi Xfix Rail SystemSummary page 2…EBl® (Biomretl® Carbon Rail Deformity K(991941, K000083, System) 1(010437,1(021031, Orthofix Adult Limb Reconstruction 1(033635, k081244… | 2002 |
| * | K033635 | Modification to Ebi Xfix Vision Fixation SystemSummary page 2…System) 1(010437,1(021031, Orthofix Adult Limb Reconstruction 1(033635, k081244 System… | 2003 |
| * | K081244 | Lower Extremity External Fixation - Expanded IndicationsSummary page 2…System) 1(010437,1(021031, Orthofix Adult Limb Reconstruction 1(033635, k081244 System Tecnologi… | 2008 |
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 14 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 37 ancestors have a recall of any class.
- 13 other devices also cite its predicate K955848.
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. 2013, 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 Newfix®D External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the…
Read the full statement (126 words)
The Newfix®D External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the stabilization of minimal fixations in intra and extra articular fractures.
The Newfix® External Fixation System lengthening components (rail systems) are unilateral external fixation devices and components intended for use in adults and pediatrics in the treatment of bone conditions including leg lengthening (osteotomies), arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122210: Newfix 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/K122210
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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