510(k) · Cleared
Recalled · Class II · 2023Smart Correction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wishbone Medical, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Sep 18, 2020 as substantially equivalent to K970748 (Smith & Nephew, Inc., Orthopaedic Div., 1997) and 5 other predicates after a 288-day review. Its family tree reaches back 14 generations to 1996. 3 later devices descend from it. It has been recalled once.
- Decided
- Sep 18, 2020
- Review
- 288 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 14 generations to K962616 (1996). 59 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 2 generations backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- 1 generation backK170650 Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl · 2017 · Recalled
- This deviceK193368 Smart Correction SystemWishbone Medical, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK231461 Smart Correction System (HA Half Pins)Wishbone Medical, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK221366 Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK252625 The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2025
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 4 generations backK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- 3 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 2 generations backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- 1 generation backK170650 Orthofix TrueLok Hexapod System (TL-HEX) V2.0Orthofix Srl · 2017 · Recalled
- This deviceK193368 Smart Correction SystemWishbone Medical, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc. · 2023 · cites it directly1descendant
- K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc. · 2022 · cites it directly1descendant
- K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −4 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| −3 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
| −2 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015 | — |
| −1 | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix Srl | 2017 | 1 |
| 0 (this device) | K193368 | Smart Correction System | Wishbone Medical, Inc. | 2020 | — |
| +1 | K231461 | Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. | 2023 | — |
| +1 | K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | Wishbone Medical, Inc. | 2022 | — |
| +1 | 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 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 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 21.4 · 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 |
|---|---|---|---|
| * | K970748 | Taylor Spatial Frame External Fixation SystemSummary page 4…II 510(k) Review Panel Orthopedic Devices (OHT6) 3. PREDICATE DEVICE(S) Primary Predicate K970748 Smith and Nephew Taylor Spatial Frame External Fixation System… | 1997 |
| * | K093047 | Smith & Nephew Circular Fixation SystemSummary page 4…K970748 Smith and Nephew Taylor Spatial Frame External Fixation System Alternate Predicate(s) K093047 Smith and Nephew Circular Fixation System K141078, K143125, K152171, & K170650 O… | 2010 |
| * | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Summary page 4…System Alternate Predicate(s) K093047 Smith and Nephew Circular Fixation System K141078, K143125, K152171, & K170650 Orthofix Truelok Hexapod System (TL-Hex System)… | 2014 |
| * | K143125 | Orthofix True Lok Hexapod System VI.3Summary page 4…System Alternate Predicate(s) K093047 Smith and Nephew Circular Fixation System K141078, K143125, K152171, & K170650 Orthofix Truelok Hexapod System (TL-Hex System)… | 2014 |
| * | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Summary page 4…tem Alternate Predicate(s) K093047 Smith and Nephew Circular Fixation System K141078, K143125, K152171, & K170650 Orthofix Truelok Hexapod System (TL-Hex System) 4.… | 2015 |
| * | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0Summary page 4…Alternate Predicate(s) K093047 Smith and Nephew Circular Fixation System K141078, K143125, K152171, & K170650 Orthofix Truelok Hexapod System (TL-Hex System) 4. DEVICE DES… | 2017 |
What descends from it? (3)
3 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 |
|---|---|---|---|---|
| Jan 4, 2023 | Class II | Z-1102-2023 | Process design | Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 18 of the 59 ancestors have a recall of any class.
- Of its descendants, K231461 (Wishbone Medical, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K970748.
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. 2020, 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 Smart Correction® System is indicated for pediatric subpopulations (excluding newborns) and adults 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 nonunions
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/K193368 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193368: Smart Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193368
Report an extraction error
Are you the manufacturer?
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