510(k) · Cleared
ClearedResponse Ortho Metaphyseal Hinge Fixator 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 Sep 18, 2024 as substantially equivalent to K001358 (Ebi, L.P., 2000) and 1 other predicate after a 90-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Sep 18, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K962616 (1996). 68 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
- 1 generation backK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020
- This deviceK241769 Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC · 2024
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK120871 Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc. · 2012
- 1 generation backK201253 Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X…Smith & Nephew · 2020
- This deviceK241769 Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −2 | K120871 | Smith & Nephew, Inc. External Fixation System Instrumentation | Smith & Nephew, Inc. | 2012 | — |
| −1 | K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator… | Smith & Nephew | 2020 | — |
| 0 (this device) | K241769 | Response Ortho Metaphyseal Hinge Fixator System | Response Ortho Solutions, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 8 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K001358 | Ebi Xfix DFS Metaphyseal Correction SystemSummary page 5….3030 Product Code(s): KTT Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K001358 EBI XFIX DFS Metaphyseal Correction System KTT K201253 Modular Rail System, TAYLOR SPATIAL FRAME… | 2000 |
| * | K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Summary page 5…3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K001358 EBI XFIX DFS Metaphyseal Correction System KTT K201253 Modular Rail System, TAYLOR SPATIAL FRAME KTT External Fixator, JET-X Fixator, ILIZAROV E… | 2020 |
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 28 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 68 ancestors have a recall of any class.
- 1 other device also cites its predicate K001358.
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. 2024, 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 Response Ortho Metaphyseal Fixation System is indicated for treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241769: Response Ortho Metaphyseal Hinge Fixator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241769
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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