510(k) · Cleared
ClearedDePuy Synthes MAXFRAME Multi-Axial Correction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 10, 2016 as substantially equivalent to K093047 (Smith & Nephew, Inc., 2010) and 1 other predicate after a 171-day review. Its family tree reaches back 10 generations to 1996. 8 later devices descend from it.
- Decided
- Nov 10, 2016
- Review
- 171 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K962616 (1996). 53 ancestors in all, the oldest K792022 (1979). 8 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- This deviceK161417 DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC · 2016
- Descendant · cites it directly · 4 of its ownK191241 AutoStrutOrthospin · 2019
- Descendant · 2 generations on · 3 of its ownK202810 AutoStrut G2Orthospin, Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK211313 MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC · 2021
- Descendant · cites it directly · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
- Descendant · 3 generations on · 1 of its ownK231922 DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes · 2023
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- This deviceK161417 DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K191241AutoStrutOrthospin · 2019 · cites it directly4descendants
- K202810AutoStrut G2Orthospin, Ltd. · 2021 · 2 generations on3descendants
- K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC · 2021 · cites it directly2descendants
- K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · cites it directly1descendant
- K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −1 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| 0 (this device) | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | Synthes USA, LLC | 2016 | — |
| +1 | K191241 | AutoStrut | Orthospin | 2019 | — |
| +2 | K202810 | AutoStrut G2 | Orthospin, Ltd. | 2021 | — |
| +1 | K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | Synthes (USA) Products, LLC | 2021 | — |
| +1 | K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025 | — |
| +3 | K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | DePuy Synthes | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 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 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K093047 | Smith & Nephew Circular Fixation SystemSummary page 5…OSN (Software for diagnosis/treatment) PREDICATE DEVICE(S) Smith & Nephew Circular Fixation System (rebranded as Taylor Spatial Frame or TSF) – K093047 Synthes Distraction Osteogenesis (DO) System – K092190 DEVICE DESCRIPTION The DePuy Synthes MAXFRAME™… | 2010 |
| * | K092190 | Synthes Distraction Osteogenesis System, MR Conditional with Expanded IndicationsSummary page 5…ircular Fixation System (rebranded as Taylor Spatial Frame or TSF) – K093047 Synthes Distraction Osteogenesis (DO) System – K092190 DEVICE DESCRIPTION The DePuy Synthes MAXFRAME™ Multi‐Axial Correction System, with adult and pediatric… | 2010 |
What descends from it? (8)
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)
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 20 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 53 ancestors have a recall of any class.
- Of its descendants, K191241 (Orthospin, 2019) has gone furthest, with 4 descendants of its own.
- 12 other devices also cite its predicate K093047.
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 DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware:
• fracture fixation (open and closed)
• pseudoarthrosis of long bones
• limb lengthening (epiphyseal or metaphyseal distraction)
• joint arthrodesis
• infected fractures or nonunions
• correction of bony or soft tissue deformities
• correction of segmental defects.
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/K161417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161417: DePuy Synthes MAXFRAME Multi-Axial Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161417
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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