510(k) · Cleared
CleareddynaMX (TM) Nitinol Compression Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mx Orthopedics, Corp. · HWC Screw, Fixation, Bone
Cleared on Jun 3, 2016 as substantially equivalent to K050636 (Synthes (Usa), 2005) after a 108-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Jun 3, 2016
- Review
- 108 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050636 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK050636 Synthes 3.0MM Headless Compression ScrewsSynthes (Usa) · 2005 · Recalled
- This deviceK160427 dynaMX (TM) Nitinol Compression ScrewMx Orthopedics, Corp. · 2016
- Descendant · cites it directly · 1 of its ownK181610 ActivOrtho Nitinol Compression Screw SystemActivortho, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK191817 ActivOrtho Continuous Compression Screw SystemActivortho, Inc. · 2019
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 |
|---|---|---|---|---|---|
| −1 | K050636 | Synthes 3.0MM Headless Compression Screws | Synthes (Usa) | 2005 | 1 |
| 0 (this device) | K160427 | dynaMX (TM) Nitinol Compression Screw | Mx Orthopedics, Corp. | 2016 | — |
| +1 | K181610 | ActivOrtho Nitinol Compression Screw System | Activortho, Inc. | 2019 | — |
| +1 | K191817 | ActivOrtho Continuous Compression Screw System | Activortho, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K050636 | Synthes 3.0MM Headless Compression ScrewsSummary page 4…oduct code: HWC - Class II 21 CFR 888.3040 Predicate Device Synthes (USA) 3.0mm Headless Compression Screw [510(k) Number K050636] Description The dynaMẌ™ Nitinol Compression Screw is a cannulated self-drilling / self-tapping screw with a threaded head whic… | 2005 |
What descends from it? (2)
2 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?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 dynaMX™ Nitinol Compression Screw is indicated for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The implants are intended for single use only.
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/K160427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160427: dynaMX (TM) Nitinol Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160427
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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