510(k) · Cleared
ClearedDarco Small Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HWC Screw, Fixation, Bone
Cleared on Nov 5, 2008 after an 84-day review. The FDA summary names no predicate by number. 1 of the 303 devices in its family, counting itself, has a Class I recall. 302 later devices descend from it.
- Decided
- Nov 5, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
302 later devices descend from it, 18 citing it directly. 1 of the 303 devices in this family, counting this one, has a Class I recall.
- This deviceK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
- Descendant · cites it directly · 97 of its ownK102429 Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010 · Recalled
- Descendant · cites it directly · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 2 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · cites it directly · 68 of its ownK112772 Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc · 2011
Showing 5 of 302 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 302 · See all- K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010 · cites it directly97descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · cites it directly79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 2 generations on74descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 3 generations on69descendants
- K112772Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc · 2011 · cites it directly68descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082320 | Darco Small Screw | Wrightmedicaltechnologyinc | 2008 | — |
| +1 | K102429 | Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw | Wrightmedicaltechnologyinc | 2010 | 1 |
| +1 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +2 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
| +3 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +1 | K112772 | Ortholoc (TM) Bone Screws | Wrightmedicaltechnologyinc | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 12 | 0 |
| 2016 | 9 | 0 |
| 2017 | 24 | 0 |
| 2018 | 9 | 0 |
| 2019 | 20 | 0 |
| 2020 | 20 | 0 |
| 2021 | 25 | 1 |
| 2022 | 25 | 0 |
| 2023 | 33 | 0 |
| 2024 | 36 | 0 |
| 2025 | 26 | 0 |
| 2026 | 45 | 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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (302)
See all 30218 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102429 | Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw | 2010 | 97 |
| K143039 | CrossRoads Screw System | 2015 | 79 |
| K112772 | Ortholoc (TM) Bone Screws | 2011 | 68 |
| K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | 2012 | 58 |
| K142658 | Biomet Headless Compression and Twist-off Screws | 2014 | 36 |
| K162353 | MICATM Screw System | 2017 | 33 |
| K133842 | Tyber Medical Trauma Screw | 2014 | 23 |
| K130319 | Medline Cannulated Screw | 2013 | 12 |
| K143460 | Cannulated Screw System | 2015 | 11 |
| K143188 | 3.Omm Biomet Cannulated Screw System | 2014 | 8 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K102429 (Wrightmedicaltechnologyinc, 2010) has gone furthest, with 97 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. 2008, 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 WRIGHTTM Compression Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082320 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082320: Darco Small Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082320
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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