510(k) · Cleared
Recalled · Class II · 2022X-Fix Line Additions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex IN Tennessee, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Mar 24, 2016 as substantially equivalent to K110069 (Smith & Nephew, Inc., 2011) and 5 other predicates after a 259-day review. Its family tree reaches back 11 generations to 1996. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 24, 2016
- Review
- 259 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 11 generations to K962616 (1996). 60 ancestors in all, the oldest K792022 (1979). 7 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 1 generation backK110069 Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011
- This deviceK151881 X-Fix Line AdditionsVilex IN Tennessee, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK223786 Orthex External Fixation SystemOrthoPediatrics Corp. · 2023
- Descendant · 2 generations on · 1 of its ownK243798 Orthex External Fixation SystemOrthoPediatrics Corp. · 2025
- Descendant · cites it directly · 1 of its ownK202054 Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK260900 DYNEX® External Fixation SystemsVilex, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK252625 The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2025
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 1 generation backK110069 Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc. · 2011
- This deviceK151881 X-Fix Line AdditionsVilex IN Tennessee, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K223786Orthex External Fixation SystemOrthoPediatrics Corp. · 2023 · cites it directly2descendants
- K243798Orthex External Fixation SystemOrthoPediatrics Corp. · 2025 · 2 generations on1descendant
- K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020 · cites it directly1descendant
- K260900DYNEX® External Fixation SystemsVilex, LLC · 2026 · 2 generations on0descendants
- K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −2 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −1 | K110069 | Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | K151881 | X-Fix Line Additions | Vilex IN Tennessee, Inc. | 2016 | — |
| +1 | K223786 | Orthex External Fixation System | OrthoPediatrics Corp. | 2023 | — |
| +2 | K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025 | — |
| +1 | K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC | 2020 | — |
| +2 | K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026 | — |
| +2 | K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K110069 | Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSummary page 4…uct Code: KTT/OSN/Orthopedics, Class II Predicate Devices: Smith & Nephew’s Taylor Spatial Frame (K110069, K093047, and K970748) Smith & Nephew’s Ilizarov External F… | 2011 |
| * | K093047 | Smith & Nephew Circular Fixation SystemSummary page 4…KTT/OSN/Orthopedics, Class II Predicate Devices: Smith & Nephew’s Taylor Spatial Frame (K110069, K093047, and K970748) Smith & Nephew’s Ilizarov External Fixator (K… | 2010 |
| * | K970748 | Taylor Spatial Frame External Fixation SystemSummary page 4…KTT/OSN/Orthopedics, Class II Predicate Devices: Smith & Nephew’s Taylor Spatial Frame (K110069, K093047, and K970748) Smith & Nephew’s Ilizarov External Fixator (K870961)… | 1997 |
| * | K870961 | Richards External Fixation SystemSummary page 4…Spatial Frame (K110069, K093047, and K970748) Smith & Nephew’s Ilizarov External Fixator (K870961) Orthofix’s TL-‐HEX Truelok Hexapod System (K141078)… | 1987 |
| * | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Summary page 4…’s Ilizarov External Fixator (K870961) Orthofix’s TL-‐HEX Truelok Hexapod System (K141078) Vilex’s X-‐Fix (K052196) Description of Device: The X… | 2014 |
| * | K052196 | Vilex X-FixSummary page 4…Orthofix’s TL-‐HEX Truelok Hexapod System (K141078) Vilex’s X-‐Fix (K052196) Description of Device: The X-‐Fix Line Additions, subject of this 510(k) submission,… | 2005 |
What descends from it? (7)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2022 | Class II | Z-0277-2023 | Under Investigation by firm | Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration. |
| Jun 29, 2022 | Class II | Z-1678-2022 | Process change control | Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 17 of the 60 ancestors have a recall of any class.
- Of its descendants, K223786 (OrthoPediatrics Corp., 2023) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K110069.
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 Vilex X-Fix is intended for external fixation with the following indications:
1. Stabilization of Fractures & Osteotomy
2. Adult and Pediatric Leg Lengthening
3. Correction of Bone Deformity in Upper & Lower Extremities
The P&C Software is intended to be used as a component of multilateral external fixation system for the indications listed above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151881: X-Fix Line Additions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151881
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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