510(k) · Cleared
ClearedDynaNail Mini
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 Feb 14, 2019 as substantially equivalent to K140741 (Wrightmedicaltechnologyinc, 2014) and 3 other predicates after a 141-day review. Its family tree reaches back 11 generations to 1996. 5 later devices descend from it.
- Decided
- Feb 14, 2019
- Review
- 141 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K962616 (1996). 79 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 1 generation backK140741 Salvation Beams and Bolts SystemWrightmedicaltechnologyinc · 2014
- This deviceK182677 DynaNail MiniMedShape, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK203381 Dynanail Mini HybridMedShape, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 2 of its ownK240530 DynaNail Mini Tapered HybridMedShape, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260995 DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK212755 SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH · 2022
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 1 generation backK140741 Salvation Beams and Bolts SystemWrightmedicaltechnologyinc · 2014
- This deviceK182677 DynaNail MiniMedShape, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K203381Dynanail Mini HybridMedShape, Inc. · 2021 · cites it directly4descendants
- K240530DynaNail Mini Tapered HybridMedShape, Inc. · 2024 · 2 generations on2descendants
- K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · cites it directly1descendant
- K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026 · cites it directly0descendants
- K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −2 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −1 | K140741 | Salvation Beams and Bolts System | Wrightmedicaltechnologyinc | 2014 | — |
| 0 (this device) | K182677 | DynaNail Mini | MedShape, Inc. | 2019 | — |
| +1 | 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 | — |
| +1 | K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026 | — |
| +2 | K212755 | SIGNUS SACRONAIL® Transsacral Stabilization System | Signus Medizintechnik GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K140741 | Salvation Beams and Bolts SystemSummary page 4…JDS, Nail, Fixation, Bone, 888.3030 E. Predicate Device(s): Wright Medical, Salvation Beams and Bolts System, K140741 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K171376 DynaNail™ Ankle Nail, Intramedullary Fixation Ro… | 2014 |
| * | K171376 | DynaNail TTC Fusion SystemSummary page 4…030 E. Predicate Device(s): Wright Medical, Salvation Beams and Bolts System, K140741 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K171376 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K101934 Synthes, 6.5mm Midfoot Fusion Bolt, K081071 ___… | 2017 |
| * | K101934 | Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222…Summary page 4…ation Beams and Bolts System, K140741 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K171376 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K101934 Synthes, 6.5mm Midfoot Fusion Bolt, K081071 ____________________________________________________________… | 2011 |
| * | K081071 | Synthes 6.5MM Midfoot Fusion BoltSummary page 4…il™ Ankle Nail, Intramedullary Fixation Rod, K171376 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K101934 Synthes, 6.5mm Midfoot Fusion Bolt, K081071 ____________________________________________________________ 1575 Northside Drive, Suite 440, Atlanta, GA 30… | 2008 |
What descends from it? (5)
3 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 23 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 17 of the 79 ancestors have a recall of any class.
- Of its descendants, K203381 (MedShape, Inc., 2021) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K140741.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Mini Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions,
and fusions of large bones 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/K182677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182677: DynaNail Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182677
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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