510(k) · Cleared
ClearedDarco Headed Cannulated 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 Jun 24, 2010 as substantially equivalent to K080101 (Aap Implantate AG, 2008) after a 132-day review. Its family tree reaches back 3 generations to 1981. 1 of the 157 devices in its family, counting itself, has a Class I recall. 145 later devices descend from it.
- Decided
- Jun 24, 2010
- Review
- 132 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K810205 (1981). 11 ancestors in all. 145 later devices descend from it, 6 citing it directly. 1 of the 157 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK810205 Mecron Cancellous Cannulated Bone ScrewsSerrano Intl. · 1981
- 2 generations backK021233 Aap Cannulated ScrewsAap Implantate AG · 2002
- 1 generation backK080101 Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008
- This deviceK100359 Darco Headed Cannulated ScrewWrightmedicaltechnologyinc · 2010
- 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 · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
- Descendant · 4 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
Showing 5 of 145 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 145 · See all- 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
- K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly58descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 4 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810205 | Mecron Cancellous Cannulated Bone Screws | Serrano Intl. | 1981 | — |
| −2 | K021233 | Aap Cannulated Screws | Aap Implantate AG | 2002 | — |
| −1 | K080101 | Aap Cannulated Screw and Darco Headed Screw | Aap Implantate AG | 2008 | — |
| 0 (this device) | K100359 | Darco Headed Cannulated Screw | Wrightmedicaltechnologyinc | 2010 | — |
| +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 | K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | Ortho Solutions Limited | 2012 | 1 |
| +4 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 10 | 0 |
| 2016 | 3 | 0 |
| 2017 | 9 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 1 |
| 2022 | 10 | 0 |
| 2023 | 17 | 0 |
| 2024 | 23 | 0 |
| 2025 | 20 | 0 |
| 2026 | 27 | 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? (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 |
|---|---|---|---|
| * | K080101 | Aap Cannulated Screw and Darco Headed ScrewSummary page 1…0--Class 1I Device Product Code & Panel: HWC: Screw, Fixation, Bone A.3. Predicate Device: aap Cannulated Screws (K080101) A.4. Device Description The DARCO® Headed Cannulated Screws will be offered in various sizes, thread types, and leng… | 2008 |
What descends from it? (145)
See all 1456 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143039 | CrossRoads Screw System | 2015 | 79 |
| K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | 2012 | 58 |
| K141784 | Ortho Solutions Ultos Plating System | 2014 | 28 |
| K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | 2011 | 8 |
| K170056 | IRENE Cannulated Screw System | 2017 | 0 |
| K132893 | Edge Orthopaedics Bite Compression Screw | 2013 | 0 |
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K143039 (Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem, 2015) has gone furthest, with 79 descendants of its own.
- 3 other devices also cite its predicate K080101.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 DARCOS Headed Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. Wright Medical's washers may be used with the screws in cases where the patient has poor bone quality. * Minimally invasive fracture / joint reconstructions * Multiple- fragment joint fractures * Simple metaphyseal fractures * Simple epiphyseal fractures o Fractures of the head of the humerus o Fractures of the head of…
Read the full statement (164 words)
The DARCOS Headed Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. Wright Medical's washers may be used with the screws in cases where the patient has poor bone quality.
* Minimally invasive fracture / joint reconstructions
* Multiple- fragment joint fractures
* Simple metaphyseal fractures
* Simple epiphyseal fractures
o Fractures of the head of the humerus
o Fractures of the head of the tibia
o Cooper fractures of the tibia
o Fractures of the radius
* Fractures of the wrist, ankle, elbow and shoulder
* Scaphoid fractures and other fractures of the hand
* Metatarsal fractures and other fractures of the foot
* Ligament fixation of the proximal humerus
* Ligament avulsion injuries (Apohysis)
* Fractures of small joint bones
o Malleolar fractures
o Navicular fractures
* Fractures of the calcaneus and talus
* Arthrodesis of the ankle joint
* Avulsion fracture and metatarsal V
* Fractures of the tarsal region
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100359: Darco Headed Cannulated Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100359
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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