510(k) · Cleared
ClearedDynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro
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 Mar 18, 2026 as substantially equivalent to K182677 (MedShape, Inc., 2019) and 6 other predicates after an 89-day review. Its family tree reaches back 14 generations to 1996. 1 later device descends from it.
- Decided
- Mar 18, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K962616 (1996). 114 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK182677 DynaNail MiniMedShape, Inc. · 2019
- 2 generations backK203381 Dynanail Mini HybridMedShape, Inc. · 2021 · Recalled
- 1 generation backK240530 DynaNail Mini Tapered HybridMedShape, Inc. · 2024
- This deviceK254110 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
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 4 generations backK140741 Salvation Beams and Bolts SystemWrightmedicaltechnologyinc · 2014
- 3 generations backK182677 DynaNail MiniMedShape, Inc. · 2019
- 2 generations backK203381 Dynanail Mini HybridMedShape, Inc. · 2021 · Recalled
- 1 generation backK240530 DynaNail Mini Tapered HybridMedShape, Inc. · 2024
- This deviceK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −4 | K140741 | Salvation Beams and Bolts System | Wrightmedicaltechnologyinc | 2014 | — |
| −3 | K182677 | DynaNail Mini | MedShape, Inc. | 2019 | — |
| −2 | K203381 | Dynanail Mini Hybrid | MedShape, Inc. | 2021 | 1 |
| −1 | K240530 | DynaNail Mini Tapered Hybrid | MedShape, Inc. | 2024 | — |
| 0 (this device) | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte… | MedShape, Inc. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (7)
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 9…below: Predicate Device Manufacturer 510K # Date Cleared DynaNail Mini (Primary Predicate) MedShape, Inc. K182677 02/14/2019 DynaNail Hybrid MedShape, Inc. K203381, 01/15/2021… | 2019 |
| * | K203381 | Dynanail Mini HybridSummary page 9…eared DynaNail Mini (Primary Predicate) MedShape, Inc. K182677 02/14/2019 DynaNail Hybrid MedShape, Inc. K203381, 01/15/2021 K240530 03/21/2024 Dyna… | 2021 |
| * | K240530 | DynaNail Mini Tapered HybridSummary page 9…/2019 DynaNail Hybrid MedShape, Inc. K203381, 01/15/2021 K240530 03/21/2024 DynaNail Helix MedShape, Inc. K203595 01/04/2022 Dyna… | 2024 |
| * | K203595 | DynaFuse Fixation SystemSummary page 9…/2021 K240530 03/21/2024 DynaNail Helix MedShape, Inc. K203595 01/04/2022 DynaClip MedShape, Inc. K181781 11/05/2018 Dyna… | 2022 |
| * | K181781 | DynaClipTM Bone StapleSummary page 9…/2024 DynaNail Helix MedShape, Inc. K203595 01/04/2022 DynaClip MedShape, Inc. K181781 11/05/2018 DynaClip Forte MedShape, Inc. K193305 04/23/2020 Dyna… | 2018 |
| * | K193305 | DynaClip Bone StapleSummary page 9…/2022 DynaClip MedShape, Inc. K181781 11/05/2018 DynaClip Forte MedShape, Inc. K193305 04/23/2020 DynaClip Delta and Quattro MedShape, Inc. K220812 08/19/2022 Dyn… | 2020 |
| * | K220812 | DynaClip® Bone StapleSummary page 9…/2018 DynaClip Forte MedShape, Inc. K193305 04/23/2020 DynaClip Delta and Quattro MedShape, Inc. K220812 08/19/2022 DynaNail TTC Fusion System (K250628) was used as a reference device in this submission. H. Basis… | 2022 |
| † | K250628 | DynaNail TTC Fusion System | 2025 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260995 | DynaNail Helix® Fixation System | 2026 | 0 |
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 2.1 years on median.
- 23 of the 114 ancestors have a recall of any class.
- Of its descendants, K260995 (MedShape, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 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 Mini and DynaNail Hybrid System are indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of short bones, long bones, small fragments or large fragments in the foot and ankle. The DynaNail Helix 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…
Read the full statement (175 words)
The DynaNail Mini and DynaNail Hybrid System are indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of short bones, long bones, small fragments or large fragments in the foot and ankle.
The DynaNail Helix 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.
The DynaClip, DynaClip Forte, DynaClip Delta, DynaClip Quattro Bone Staples are indicated for
* Fracture, osteotomy fixation and joint arthrodesis of the hand and foot.
* Fixation of proximal tibial metaphysis osteotomy.
* Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula, and sternum.
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/K254110 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254110: DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254110
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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