510(k) · Cleared
CleareddynaMX Intramedullary Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HTY Pin, Fixation, Smooth
Cleared on Jul 20, 2017 as substantially equivalent to K960385 (Depuy, Inc., 1996) and 4 other predicates after a 168-day review. Its family tree reaches back 6 generations to 2002. 2 later devices descend from it.
- Decided
- Jul 20, 2017
- Review
- 168 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K013888 (2002). 22 ancestors in all, the oldest K954330 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
- 5 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
- 4 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- 3 generations backK111536 Metasurg Digifuse ImplantMetasurg · 2011
- 2 generations backK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
- 1 generation backK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
- This deviceK170326 dynaMX Intramedullary ImplantArthrex, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK190287 Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK231147 Hammerdesis™ Interphalangeal Fusion SystemIntelivation · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013888 | Fixation (Steinmann) Pins | Miltex, Inc. | 2002 | — |
| −5 | K031050 | PCW Percutaneous Compression Wire | Millennium Medical Technologies, Inc. | 2003 | — |
| −4 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| −3 | K111536 | Metasurg Digifuse Implant | Metasurg | 2011 | — |
| −2 | K122959 | Hammer Toe Implant | Trilliant Surgical, Ltd. | 2012 | 1 |
| −1 | K140148 | Pro-Toe Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2014 | — |
| 0 (this device) | K170326 | dynaMX Intramedullary Implant | Arthrex, Inc. | 2017 | — |
| +1 | K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | Arthrex, Inc. | 2019 | — |
| +2 | K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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 |
|---|---|---|---|
| * | K960385 | Sterile Kirschner Wires and Steinmann PinsSummary page 4…888.3040 Predicate Device DePuy (Primary Predicate) Sterile Kirschner Wires and Steinmann Pins [510(k) Number K960385] OrthoHelix Intraosseous Fixation System [510(k) Number… | 1996 |
| * | K120165 | Intraosseous Fixation SystemSummary page 4…[510(k) Number K960385] OrthoHelix Intraosseous Fixation System [510(k) Number K120165] Wright Medical PRO-TOE® Hammertoe Fixation System [510(k) N… | 2012 |
| * | K140148 | Pro-Toe Hammertoe Fixation SystemSummary page 4…[510(k) Number K120165] Wright Medical PRO-TOE® Hammertoe Fixation System [510(k) Number K140148] BioMedical Enterprises HammerLock® 2 [510(k) Number K133520]… | 2014 |
| * | K133520 | Hammerlock 2Summary page 4…[510(k) Number K140148] BioMedical Enterprises HammerLock® 2 [510(k) Number K133520] Memometal Technologies Smart Toe and X-Fuse [510(k) Number K070598]… | 2014 |
| * | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseSummary page 4…[510(k) Number K133520] Memometal Technologies Smart Toe and X-Fuse [510(k) Number K070598] K170326 - Page 2 of 5 Description The dynaMẌ™ Intramedullary Implant… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | 2019 | 1 |
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 15 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K190287 (Arthrex, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 16 other devices also cite its predicate K960385.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The dynaMX™ Intramedullary Fixation Device is indicated to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
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/K170326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170326: dynaMX Intramedullary Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170326
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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