510(k) · Cleared
ClearedAccessories for the SixFix® Hexapod Fixator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrowhead De, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Sep 22, 2020 as substantially equivalent to K190069 (Arrowhead De, LLC, 2019) and 4 other predicates after a 245-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Sep 22, 2020
- Review
- 245 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K962616 (1996). 73 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- 2 generations backK180539 Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC · 2018
- 1 generation backK190069 SixFix™ Hexapod Fixator and Deformity Analysis and Correction…Arrowhead De, LLC · 2019
- This deviceK200123 Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC · 2020
Show all 15 generations
- Root · 15 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 13 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 12 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 11 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 9 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 8 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 7 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 6 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 5 generations backK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- 4 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 3 generations backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- 2 generations backK180539 Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC · 2018
- 1 generation backK190069 SixFix™ Hexapod Fixator and Deformity Analysis and Correction…Arrowhead De, LLC · 2019
- This deviceK200123 Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −14 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −13 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −12 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −11 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −9 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −8 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −7 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −6 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −5 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| −4 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
| −3 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015 | — |
| −2 | K180539 | Deformity Analysis and Correction Software (DACS) and Instrumentation | Arrowhead Medical Device Technologies, LLC | 2018 | — |
| −1 | K190069 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Arrowhead De, LLC | 2019 | — |
| 0 (this device) | K200123 | Accessories for the SixFix® Hexapod Fixator | Arrowhead De, LLC | 2020 | — |
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 | 8 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K190069 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Summary page 4…Date Primary Predicate SixFix Hexapod Fixator AMDT K190069 May 14, 2019 Secondary Predicates TL-HEX TRUELOK External Orthofix Srl K141078 Se… | 2019 |
| * | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Summary page 4…pod Fixator AMDT K190069 May 14, 2019 Secondary Predicates TL-HEX TRUELOK External Orthofix Srl K141078 September 2, 2014 Fixation System Hoffman LRF System Stryker GmbH K161753 Novemb… | 2014 |
| * | K161753 | Hoffman LRF SystemSummary page 4…RUELOK External Orthofix Srl K141078 September 2, 2014 Fixation System Hoffman LRF System Stryker GmbH K161753 November 15, 2016 K163656 April 14, 2017… | 2016 |
| * | K163656 | Hoffmann LRF SystemSummary page 4…System Hoffman LRF System Stryker GmbH K161753 November 15, 2016 K163656 April 14, 2017 K182968 January 25, 2019 IV.… | 2017 |
| * | K182968 | Hoffmann LRF SystemSummary page 4…15, 2016 K163656 April 14, 2017 K182968 January 25, 2019 IV. Device Description The SixFix Hexapod Fixator is a multilateral circular external fixation system… | 2019 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 21 of the 73 ancestors have a recall of any class.
- 2 other devices also cite its predicate K190069.
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?
INDICATIONS for Accessories for the SixFix Hexapod Fixator (Reduction Struts, Foot Arches with Locking Hinges,
Motion Hinge, Variable Angle Clamps)
The SixFix® Hexapod Fixator is intended to be used for post-traumatic joint contracture which has resulted in loss of
range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and
fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by
epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue
defects; joint arthrodesis; infected fractures or nonunions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200123 · printed Nov 5, 2026
Cite this page
510(k) Report. “K200123: Accessories for the SixFix® Hexapod Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K200123
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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