510(k) · Cleared
ClearedDeformity Analysis and Correction Software (DACS) and Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrowhead Medical Device Technologies, LLC · OSN Software For Diagnosis/Treatment
Cleared on Aug 13, 2018 as substantially equivalent to K110069 (Smith & Nephew, Inc., 2011) and 5 other predicates after a 166-day review. Its family tree reaches back 13 generations to 1996. 4 later devices descend from it.
- Decided
- Aug 13, 2018
- Review
- 166 days
- Class
- Class II
- Product code
- OSN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K962616 (1996). 60 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- 2 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 1 generation backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- This deviceK180539 Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC · 2018
- Descendant · cites it directly · 3 of its ownK190069 SixFix™ Hexapod Fixator and Deformity Analysis and Correction…Arrowhead De, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK253764 ENOS Software Guided External Fixation SystemDisior, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK250472 SixFix™ Hexapod Fixator and Deformity Analysis and Correction…Amdt Holdings, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK200123 Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC · 2020
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 4 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 3 generations backK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- 2 generations backK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
- 1 generation backK152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl · 2015
- This deviceK180539 Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC · 2019 · cites it directly3descendants
- K253764ENOS Software Guided External Fixation SystemDisior, Ltd. · 2026 · 2 generations on0descendants
- K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc. · 2025 · 2 generations on0descendants
- K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −4 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −3 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| −2 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
| −1 | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 | Orthofix Srl | 2015 | — |
| 0 (this device) | 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 | — |
| +2 | K253764 | ENOS Software Guided External Fixation System | Disior, Ltd. | 2026 | — |
| +2 | K250472 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | 2025 | — |
| +2 | 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 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 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 OSN? 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 OSN device
- #1 K253764 ENOS Software Guided External Fixation Systemscore 15.1 · 15 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K110069 | Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSummary page 4…rer 510(k) Clearance No. Date Taylor Spatial Frame Smith & Nephew K110069 02/08/2011 (TSF) K093047 09/27/2010… | 2011 |
| * | K093047 | Smith & Nephew Circular Fixation SystemSummary page 4…No. Date Taylor Spatial Frame Smith & Nephew K110069 02/08/2011 (TSF) K093047 09/27/2010 K970748 05/09/1997 TL-HEX Truelok… | 2010 |
| * | K970748 | Taylor Spatial Frame External Fixation SystemSummary page 4…w K110069 02/08/2011 (TSF) K093047 09/27/2010 K970748 05/09/1997 TL-HEX Truelok Orthofix K141078 09/02/2014 Hexapod System… | 1997 |
| * | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Summary page 4…K093047 09/27/2010 K970748 05/09/1997 TL-HEX Truelok Orthofix K141078 09/02/2014 Hexapod System K152171 09/28/2015 OrthoHub Exter… | 2014 |
| * | K152171 | Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Summary page 4…K970748 05/09/1997 TL-HEX Truelok Orthofix K141078 09/02/2014 Hexapod System K152171 09/28/2015 OrthoHub External OrthoHub K140550 08/25/2014 Fixator Softwa… | 2015 |
| * | K140550 | Orthohub External Fixator SoftwareSummary page 4…K141078 09/02/2014 Hexapod System K152171 09/28/2015 OrthoHub External OrthoHub K140550 08/25/2014 Fixator Software 1|Page… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190069 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | 2019 | 3 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 17 of the 60 ancestors have a recall of any class.
- Of its descendants, K190069 (Arrowhead De, LLC, 2019) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K110069.
How does its category compare?
All OSN devicesOSN Software For Diagnosis/Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OSN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OSN
Too few OSN 510(k)s in any year since 2007 to give a median.
Recalls per year · OSN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OSN
9in 2023
MAUDE reports naming product code OSN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 1 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 1 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Deformity Analysis and Correction Software (DACS) and Instrumentation are intended to be used as components of the Smith & Nephew Taylor Spatial Frame external fixation system that is indicated for the following: 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/K180539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180539: Deformity Analysis and Correction Software (DACS) and Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180539
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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