510(k) · Cleared
ClearedHand Trauma Screw 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 May 12, 2022 as substantially equivalent to K201662 (Skeletal Dynamics, Inc., 2020) and 1 other predicate after a 59-day review. Its family tree reaches back 4 generations to 2003. 1 later device descends from it.
- Decided
- May 12, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K030302 (2003). 8 ancestors in all, the oldest K973309 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK030302 HBS Headless Bone ScrewSchoening & Assoc., Inc. · 2003
- 3 generations backK112672 Headless Compression ScrewSkeletal Dynamics, LLC · 2011
- 2 generations backK143624 Headless Compression Screw SystemSkeletal Dynamics, LLC · 2015
- 1 generation backK201662 REDUCT® Headless Compression Screw SystemSkeletal Dynamics, Inc. · 2020
- This deviceK220723 Hand Trauma Screw SystemSkeletal Dynamics, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK230908 Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230908Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K030302 | HBS Headless Bone Screw | Schoening & Assoc., Inc. | 2003 | — |
| −3 | K112672 | Headless Compression Screw | Skeletal Dynamics, LLC | 2011 | — |
| −2 | K143624 | Headless Compression Screw System | Skeletal Dynamics, LLC | 2015 | — |
| −1 | K201662 | REDUCT® Headless Compression Screw System | Skeletal Dynamics, Inc. | 2020 | — |
| 0 (this device) | K220723 | Hand Trauma Screw System | Skeletal Dynamics, Inc. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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 |
|---|---|---|---|
| * | K201662 | REDUCT® Headless Compression Screw SystemSummary page 4…ner Classification Number: 21 CFR §888.3040 Regulatory Class: Class II Product Code: HWC Predicate Devices Primary predicate device: REDUCT® Headless Compression Screw, K201662 Additional predicate device: Tyber Medical Trauma Screws, K133842 Device Description The Skeletal Dynamic’s Hand Trauma Screw Sy… | 2020 |
| * | K133842 | Tyber Medical Trauma ScrewSummary page 4…s II Product Code: HWC Predicate Devices Primary predicate device: REDUCT® Headless Compression Screw, K201662 Additional predicate device: Tyber Medical Trauma Screws, K133842 Device Description The Skeletal Dynamic’s Hand Trauma Screw System consists of titanium screws and specialized instrumentation.… | 2014 |
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 |
|---|---|---|---|
| K230908 | Hand Trauma Threaded Nail System | 2023 | 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 19 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K230908 (Skeletal Dynamics, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Screw System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220723: Hand Trauma Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220723
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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