510(k) · Cleared
ClearedAap Cannulated Screw and Darco Headed Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aap Implantate AG · HWC Screw, Fixation, Bone
Cleared on Mar 25, 2008 as substantially equivalent to K021233 (Aap Implantate AG, 2002) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 1981. 1 of the 191 devices in its family, counting itself, has a Class I recall. 180 later devices descend from it.
- Decided
- Mar 25, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K810205 (1981). 10 ancestors in all. 180 later devices descend from it, 4 citing it directly. 1 of the 191 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK810205 Mecron Cancellous Cannulated Bone ScrewsSerrano Intl. · 1981
- 1 generation backK021233 Aap Cannulated ScrewsAap Implantate AG · 2002
- This deviceK080101 Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008
- Descendant · cites it directly · 145 of its ownK100359 Darco Headed Cannulated ScrewWrightmedicaltechnologyinc · 2010
- Descendant · 2 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 3 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
- Descendant · 4 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
Showing 5 of 180 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 180 · See all- K100359Darco Headed Cannulated ScrewWrightmedicaltechnologyinc · 2010 · cites it directly145descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 3 generations on74descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 4 generations on69descendants
- K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · 2 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810205 | Mecron Cancellous Cannulated Bone Screws | Serrano Intl. | 1981 | — |
| −1 | K021233 | Aap Cannulated Screws | Aap Implantate AG | 2002 | — |
| 0 (this device) | K080101 | Aap Cannulated Screw and Darco Headed Screw | Aap Implantate AG | 2008 | — |
| +1 | K100359 | Darco Headed Cannulated Screw | Wrightmedicaltechnologyinc | 2010 | — |
| +2 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +3 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
| +4 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +2 | K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | Ortho Solutions Limited | 2012 | 1 |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 11 | 0 |
| 2016 | 4 | 0 |
| 2017 | 11 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 10 | 1 |
| 2022 | 15 | 0 |
| 2023 | 21 | 0 |
| 2024 | 27 | 0 |
| 2025 | 22 | 0 |
| 2026 | 30 | 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? (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 |
|---|---|---|---|
| * | K021233 | Aap Cannulated ScrewsSummary page 2…material, and indications for use of the Qap Cannulated Screws are substantially equivalent to the previously cleared oap Small and Large Cannulated Screw System (K021233) and oap Cannulated Screws and Washers (990776). The safety and effectiveness of the cap Cannulated Screws is adequately su… | 2002 |
| * | K990776 | Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MMSummary page 2…lated Screws are substantially equivalent to the previously cleared oap Small and Large Cannulated Screw System (K021233) and oap Cannulated Screws and Washers (990776). The safety and effectiveness of the cap Cannulated Screws is adequately supported by the substantial equivalence information… | 1999 |
What descends from it? (180)
See all 1804 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 21.8 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K100359 (Wrightmedicaltechnologyinc, 2010) has gone furthest, with 145 descendants of its own.
- 2 other devices also cite its predicate K021233.
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 nap Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aap's washers may be used with the screws in certain applications. * Minimally invasive fracture /joint reconstructions * Additive osteosynthesis for complex joint fractures * Multiple- fragment joint fractures * Femoral neck and femoral head fractures Femoral supracondylar fractures Tibial plateau fractures Simple metaphyseal…
Read the full statement (187 words)
The nap Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aap's washers may be used with the screws in certain applications.
* Minimally invasive fracture /joint reconstructions
* Additive osteosynthesis for complex joint fractures
* Multiple- fragment joint fractures
* Femoral neck and femoral head fractures
Femoral supracondylar fractures
Tibial plateau 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
Fractures of the acetabulum
Fractures of the dorsal pelvic ring
Condylar fractures
Peadiatric epiphyseal and metaphyseal fractures
* 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 metatarsl V
* Fractures of the tarsal region
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080101: Aap Cannulated Screw and Darco Headed Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080101
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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