510(k) · Cleared
ClearedDarco Headless Compression 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 Apr 10, 2008 after a 15-day review. The FDA summary names no predicate by number. 17 later devices descend from it.
- Decided
- Apr 10, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 5 citing it directly.
- This deviceK080850 Darco Headless Compression ScrewWrightmedicaltechnologyinc · 2008
- Descendant · cites it directly · 8 of its ownK133460 Aptus Cannulated Compression ScrewsMedartis AG · 2013
- Descendant · 2 generations on · 6 of its ownK202589 APTUS Cannulated Compression Screws, APTUS headed Cannulated…Medartis AG · 2020 · Recalled
- Descendant · cites it directly · 3 of its ownK133451 Fixos Screw SystemStryker Trauma AG · 2014
- Descendant · 3 generations on · 2 of its ownK211783 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK200291 CREED™ Cannulated ScrewsGlw Medical, Inc. · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K133460Aptus Cannulated Compression ScrewsMedartis AG · 2013 · cites it directly8descendants
- K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG · 2020 · 2 generations on6descendants
- K133451Fixos Screw SystemStryker Trauma AG · 2014 · cites it directly3descendants
- K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021 · 3 generations on2descendants
- K200291CREED™ Cannulated ScrewsGlw Medical, Inc. · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080850 | Darco Headless Compression Screw | Wrightmedicaltechnologyinc | 2008 | — |
| +1 | K133460 | Aptus Cannulated Compression Screws | Medartis AG | 2013 | — |
| +2 | K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression… | Medartis AG | 2020 | 1 |
| +1 | K133451 | Fixos Screw System | Stryker Trauma AG | 2014 | — |
| +3 | K211783 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2021 | — |
| +1 | K200291 | CREED™ Cannulated Screws | Glw Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 22.3 · 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? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K133460 (Medartis AG, 2013) has gone furthest, with 8 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 7.0mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: * Fixation of bone fragments, in long bones or small bones fractures * Fracture management in the foot or hand * Arthrodesis in hand, foot or ankle surgery * Mono or Bi-cortical osteotomies in the foot or hand or in long bones * Treatment of inferior tibio fibular diastasis * Hindfoot arthrodesis The 4.3mm DARCO® Headless…
Read the full statement (160 words)
The 7.0mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
* Fixation of bone fragments, in long bones or small bones fractures
* Fracture management in the foot or hand
* Arthrodesis in hand, foot or ankle surgery
* Mono or Bi-cortical osteotomies in the foot or hand or in long bones
* Treatment of inferior tibio fibular diastasis
* Hindfoot arthrodesis
The 4.3mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
* Mono or Bi-Cortical osteotomies in the foot or hand
* Distal or Proximal metatarsal or metacarpal osteotomies
* Weil osteotomy
* Fusion of the first metatarsophalangeal joint and interphalangeal joint
* Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
* Akin type osteotomy
* Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
* Calcaneus/ cuboid arthrodesis
* Talar/ navicular arthrodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080850 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080850: Darco Headless Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080850
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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