510(k) · Cleared
ClearedREDUCT® Headless Compression 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 Jul 16, 2020 as substantially equivalent to K143624 (Skeletal Dynamics, LLC, 2015) after a 27-day review. Its family tree reaches back 3 generations to 2003. 2 later devices descend from it.
- Decided
- Jul 16, 2020
- Review
- 27 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K030302 (2003). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK030302 HBS Headless Bone ScrewSchoening & Assoc., Inc. · 2003
- 2 generations backK112672 Headless Compression ScrewSkeletal Dynamics, LLC · 2011
- 1 generation backK143624 Headless Compression Screw SystemSkeletal Dynamics, LLC · 2015
- This deviceK201662 REDUCT® Headless Compression Screw SystemSkeletal Dynamics, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK220723 Hand Trauma Screw SystemSkeletal Dynamics, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK230908 Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc. · 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 |
|---|---|---|---|---|---|
| −3 | K030302 | HBS Headless Bone Screw | Schoening & Assoc., Inc. | 2003 | — |
| −2 | K112672 | Headless Compression Screw | Skeletal Dynamics, LLC | 2011 | — |
| −1 | K143624 | Headless Compression Screw System | Skeletal Dynamics, LLC | 2015 | — |
| 0 (this device) | K201662 | REDUCT® Headless Compression Screw System | Skeletal Dynamics, Inc. | 2020 | — |
| +1 | K220723 | Hand Trauma Screw System | Skeletal Dynamics, Inc. | 2022 | — |
| +2 | K230908 | Hand Trauma Threaded Nail System | Skeletal Dynamics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 |
|---|---|---|---|
| * | K143624 | Headless Compression Screw SystemSummary page 4…crew System Common Name: Screw, Fixation, Bone Classification: 21 CFR §888.3040 Regulatory Class: Class II Product Code(s): HWC Predicate Device: K143624, 1/13/2015 Skeletal Dynamics Headless Compression Screw System Device Description The REDUCT® Headless Compression Screw (HCS) Sy… | 2015 |
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 |
|---|---|---|---|
| K220723 | Hand Trauma Screw System | 2022 | 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 17 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220723 (Skeletal Dynamics, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K143624.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Skeletal Dynamics REDUCT® Headless Compression Screw System is intended for 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/K201662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201662: REDUCT® Headless Compression 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/K201662
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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