510(k) · Cleared
ClearedThe Response Ortho Smart Fixator - Hexapod System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Response Ortho Solutions, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 20, 2025 as substantially equivalent to K193368 (Wishbone Medical, Inc., 2020) and 4 other predicates after a 93-day review. Its family tree reaches back 16 generations to 1996.
- Decided
- Nov 20, 2025
- Review
- 93 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K962616 (1996). 112 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations between
- 3 generations backK170650 Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl · 2017 · Recalled
- 2 generations backK193368 Smart Correction SystemWishbone Medical, Inc. · 2020 · Recalled
- 1 generation backK221366 Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc. · 2022
- This deviceK252625 The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2025
Show all 16 generations
- Root · 16 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 15 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 14 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 13 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 12 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 10 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 9 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 8 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 7 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 6 generations backK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- 5 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 4 generations backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- 3 generations backK170650 Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl · 2017 · Recalled
- 2 generations backK193368 Smart Correction SystemWishbone Medical, Inc. · 2020 · Recalled
- 1 generation backK221366 Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc. · 2022
- This deviceK252625 The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −15 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −14 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −13 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −12 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −10 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −9 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −8 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −7 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −6 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| −5 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
| −4 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015 | — |
| −3 | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix Srl | 2017 | 1 |
| −2 | K193368 | Smart Correction System | Wishbone Medical, Inc. | 2020 | 1 |
| −1 | K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | Wishbone Medical, Inc. | 2022 | — |
| 0 (this device) | 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 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 9 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K193368 | Smart Correction SystemSummary page 7…vice was also tested. Test results of subject and predicate devices were prepared and presented in comparison reports. Based on the comparison to the predicate devices (K193368, K221366, and K231461), and results from verification and validation testing including mechanical testing, biocompatibility evalu… | 2020 |
| * | K221366 | Smart Correction System Rings and Compatible HA-Coated Half PinsSummary page 5…I �I K_T _T ___ __, I K 2213 66 I S�art Correction System Rings and Compatible HA-Coated �--------' Pins… | 2022 |
| * | K231461 | Smart Correction System (HA Half Pins)Summary page 7…Test results of subject and predicate devices were prepared and presented in comparison reports. Based on the comparison to the predicate devices (K193368, K221366, and K231461), and results from verification and validation testing including mechanical testing, biocompatibility evaluation, sterilization v… | 2023 |
| * | K223786 | Orthex External Fixation System | 2023 |
| * | K243798 | Orthex External Fixation SystemSummary page 5…KT _ ___ � I K 24379 8 11 OrthexExternal Fixation System… | 2025 |
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 29 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 22 of the 112 ancestors have a recall of any class.
- 2 other devices also cite its predicate K193368.
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. 2025, 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?
INTENDED USE The Response Ortho Smart Fixator - Hexapod System is intended for use in adult patients and pediatric patients greater than 2 through 21 years of age for the treatment of open and closed fractures, arthrodesis and pseudoarthrosis of long bones, limb lengthening, deformity and angular correction, bony or soft tissue defect correction, and malunions. This is accomplished by construction of an external fixator frame and a computer-assisted…
Read the full statement (204 words)
INTENDED USE
The Response Ortho Smart Fixator - Hexapod System is intended for use in adult patients and pediatric patients greater than 2 through 21 years of age for the treatment of open and closed fractures, arthrodesis and pseudoarthrosis of long bones, limb lengthening, deformity and angular correction, bony or soft tissue defect correction, and malunions. This is accomplished by construction of an external fixator frame and a computer-assisted planning and correction application. Based on surgeon input of examination and radiographic measurements, the software provides a schedule of adjustments for the fixator frame.
INDICATIONS FOR USE
The Smart Fixator - Hexapod System is indicated for adult patients and pediatric patients greater than 2 through 21 years of age for the following:
* Joint contracture resulting in loss of range of motion.
* Fractures and disease which generally may result in joint contractures or loss of range of motion.
* Fractures requiring distraction.
* Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar).
* Correction of bony or soft tissue defects.
* Correction of bony or soft tissue deformities.
* Joint arthrodesis.
* Infected fractures or nonunion.
* Limb lengthening by epiphyseal or metaphyseal distraction.
* Pseudoarthrosis of long bones.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252625: The Response Ortho Smart Fixator - Hexapod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252625
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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