510(k) · Cleared
ClearedHand Trauma Threaded Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, Inc. · HWC Screw, Fixation, Bone
Cleared on Apr 28, 2023 as substantially equivalent to K220723 (Skeletal Dynamics, Inc., 2022) after a 28-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Apr 28, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K030302 (2003). 9 ancestors in all, the oldest K973309 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK030302 HBS Headless Bone ScrewSchoening & Assoc., Inc. · 2003
- 4 generations backK112672 Headless Compression ScrewSkeletal Dynamics, LLC · 2011
- 3 generations backK143624 Headless Compression Screw SystemSkeletal Dynamics, LLC · 2015
- 2 generations backK201662 REDUCT® Headless Compression Screw SystemSkeletal Dynamics, Inc. · 2020
- 1 generation backK220723 Hand Trauma Screw SystemSkeletal Dynamics, Inc. · 2022
- This deviceK230908 Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K030302 | HBS Headless Bone Screw | Schoening & Assoc., Inc. | 2003 | — |
| −4 | K112672 | Headless Compression Screw | Skeletal Dynamics, LLC | 2011 | — |
| −3 | K143624 | Headless Compression Screw System | Skeletal Dynamics, LLC | 2015 | — |
| −2 | K201662 | REDUCT® Headless Compression Screw System | Skeletal Dynamics, Inc. | 2020 | — |
| −1 | K220723 | Hand Trauma Screw System | Skeletal Dynamics, Inc. | 2022 | — |
| 0 (this device) | K230908 | Hand Trauma Threaded Nail System | Skeletal Dynamics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K220723 | Hand Trauma Screw SystemSummary page 4…hreaded Metallic Bone Fixation Fastener Classification Number: 21 CFR §888.3040 Regulatory Class: Class II Product Code: HWC Predicate Devices Hand Trauma Screw System, K220723 Device Description The Skeletal Dynamic’s Hand Trauma Threaded Nail System consists of cannulated and non- cannulated threaded n… | 2022 |
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 20 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Hand Trauma Threaded Nail System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized threaded nail.
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/K230908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230908: Hand Trauma Threaded Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230908
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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