510(k) · Cleared
ClearedAap Cannulated Screws
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 Jul 20, 2011 as substantially equivalent to K021233 (Aap Implantate AG, 2002) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1981. 39 later devices descend from it.
- Decided
- Jul 20, 2011
- Review
- 71 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K810205 (1981). 11 ancestors in all. 39 later devices descend from it, 3 citing it directly.
- 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 deviceK111316 Aap Cannulated ScrewsAap Implantate AG · 2011
- Descendant · cites it directly · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
- Descendant · 2 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- Descendant · 3 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- Descendant · 2 generations on · 9 of its ownK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
- Descendant · 4 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · cites it directly36descendants
- K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 2 generations on21descendants
- K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 3 generations on9descendants
- K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015 · 2 generations on9descendants
- K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 4 generations on8descendants
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) | K111316 | Aap Cannulated Screws | Aap Implantate AG | 2011 | — |
| +1 | K123890 | Acumed Cannulated Screw System | Acumed, LLC | 2013 | 2 |
| +2 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| +3 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| +2 | K150693 | PHIN-FX Cannulated Lag Screw System | Ascent Medical, LLC | 2015 | — |
| +4 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (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 3…ION OF DEVICE MODIFICATION This special 510(k) submission is intended to introduce a line extension to the predicate aap Small and Large Cannulated Screw System (K021233) and aap Cannulated Screws (KO80101), which consists of the addition of new overall lengths and thread lengths both for t… | 2002 |
| * | K080101 | Aap Cannulated Screw and Darco Headed ScrewSummary page 3…or use. Mechanical tests per ASTM F543 were conducted for those screws for which no test reports have been provided with the predicate device submissions K021233 and K080101 to verify the safety and effectiveness of the additional screws. Page 3 of 3 === Page… | 2008 |
What descends from it? (39)
See all 393 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?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K123890 (Acumed, LLC, 2013) has gone furthest, with 36 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. 2011, 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 aap 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 reconstruction of fractures and joints * adjuvant for osteosynthesis in complex joint fractures * multifragment joint fractures * fractures of the femoral head and neck * supracondylar femoral fractures * tibial plateau fractures * simple…
Read the full statement (191 words)
The aap 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 reconstruction of fractures and joints
* adjuvant for osteosynthesis in complex joint fractures
* multifragment joint fractures
* fractures of the femoral head and neck
* supracondylar femoral fractures
* tibial plateau fractures
* simple metaphyseal fractures
* simple epiphyseal fractures such as:
o fractures of the humeral head
o fractures of the tibial plateau
o pilon fractures
o fractures of the radius
* fractures of the wrist, ankle, elbow, and shoulder
* scaphoid fracture and other fractures of the hand
* metatarsal fractures and other fractures of the foot
* ligament fixation at the proximal humerus
* acetabular fractures
* fractures of the posterior pelvic ring
* condylar fractures
* epiphyseal and metaphyseal fractures in children
* ligament avulsion injuries
* fractures of small joints, such as:
o ankle fractures
o navicular fractures
* calcaneal and talar fractures
* arthrodesis of the ankle
* avulsion fractures and fractures of metatarsal V
* tarsal fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111316: Aap Cannulated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111316
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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