510(k) · Cleared
ClearedDynaNail Helix® Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MedShape, Inc. · HWC Screw, Fixation, Bone
Cleared on Sep 23, 2026 as substantially equivalent to K182677 (MedShape, Inc., 2019) and 3 other predicates after a 181-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Sep 23, 2026
- Review
- 181 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K962616 (1996). 115 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 backK203381 Dynanail Mini HybridMedShape, Inc. · 2021 · Recalled
- 2 generations backK240530 DynaNail Mini Tapered HybridMedShape, Inc. · 2024
- 1 generation backK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
- This deviceK260995 DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
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 backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 5 generations backK140741 Salvation Beams and Bolts SystemWrightmedicaltechnologyinc · 2014
- 4 generations backK182677 DynaNail MiniMedShape, Inc. · 2019
- 3 generations backK203381 Dynanail Mini HybridMedShape, Inc. · 2021 · Recalled
- 2 generations backK240530 DynaNail Mini Tapered HybridMedShape, Inc. · 2024
- 1 generation backK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
- This deviceK260995 DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
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 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −5 | K140741 | Salvation Beams and Bolts System | Wrightmedicaltechnologyinc | 2014 | — |
| −4 | K182677 | DynaNail Mini | MedShape, Inc. | 2019 | — |
| −3 | K203381 | Dynanail Mini Hybrid | MedShape, Inc. | 2021 | 1 |
| −2 | K240530 | DynaNail Mini Tapered Hybrid | MedShape, Inc. | 2024 | — |
| −1 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte… | MedShape, Inc. | 2026 | — |
| 0 (this device) | K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 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? (4)
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 |
|---|---|---|---|
| * | K182677 | DynaNail MiniSummary page 6…995 Predicate Device Manufacturer 510K # Date Cleared DynaNail Mini MedShape, Inc. K182677 02/14/2019 DynaFuse Fixation System (Primary) MedShape, Inc. K203595 01/04/2022 DynaNail He… | 2019 |
| * | K203595 | DynaFuse Fixation SystemSummary page 6…ared DynaNail Mini MedShape, Inc. K182677 02/14/2019 DynaFuse Fixation System (Primary) MedShape, Inc. K203595 01/04/2022 DynaNail Helix MedShape, Inc. K254110 03/18/2026 Tiger Cannu… | 2022 |
| * | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…Summary page 6…2019 DynaFuse Fixation System (Primary) MedShape, Inc. K203595 01/04/2022 DynaNail Helix MedShape, Inc. K254110 03/18/2026 Tiger Cannulated Screw System Trilliant Surgical Ltd K153338 01/14/2016 H. Basis for… | 2026 |
| * | K153338 | Tiger Cannulated Screw SystemSummary page 6…2022 DynaNail Helix MedShape, Inc. K254110 03/18/2026 Tiger Cannulated Screw System Trilliant Surgical Ltd K153338 01/14/2016 H. Basis for Submission: This Traditional 510(k) submission serves as notification to the agency of a l… | 2016 |
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 30 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 23 of the 115 ancestors have a recall of any class.
- 2 other devices also cite its predicate K182677.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The DynaNail Helix® Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device such as short bones, long bones, and small or large fragments in the foot and ankle.
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/K260995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260995: DynaNail Helix® Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260995
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026