510(k) · Cleared
ClearedCannulated Headless Bone 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 Jun 5, 2024 as substantially equivalent to K111316 (Aap Implantate AG, 2011) after a 257-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Jun 5, 2024
- Review
- 257 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K810205 (1981). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK810205 Mecron Cancellous Cannulated Bone ScrewsSerrano Intl. · 1981
- 3 generations backK021233 Aap Cannulated ScrewsAap Implantate AG · 2002
- 2 generations backK080101 Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG · 2008
- 1 generation backK111316 Aap Cannulated ScrewsAap Implantate AG · 2011
- This deviceK233008 Cannulated Headless Bone ScrewsAap Implantate AG · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K810205 | Mecron Cancellous Cannulated Bone Screws | Serrano Intl. | 1981 | — |
| −3 | K021233 | Aap Cannulated Screws | Aap Implantate AG | 2002 | — |
| −2 | K080101 | Aap Cannulated Screw and Darco Headed Screw | Aap Implantate AG | 2008 | — |
| −1 | K111316 | Aap Cannulated Screws | Aap Implantate AG | 2011 | — |
| 0 (this device) | K233008 | Cannulated Headless Bone Screws | Aap Implantate AG | 2024 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K111316 | Aap Cannulated ScrewsSummary page 5…pedic Devices) Reviewing Division Division of Health Technology 6 C (Restorative, Repair and Trauma Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K111316, aap Cannulated Screws, aap Implantate AG Reference Devices K130590, aap Cannulated Screw 2.0, aap Implantate AG K131459, aap Wi… | 2011 |
| † | K130590 | Aap Cannulated Screw 2.0 | 2013 |
| † | K131459 | Aap K-Wire, Steinmann Pin, Cerclage Wire | 2013 |
| † | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 43 years and passes through 2 companies; a new generation was cleared every 12.9 years on median.
- None of the 12 ancestors has a recall.
- 2 other devices also cite its predicate K111316.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Cannulated Headless Bone Screws The aap Cannulated Headless Bone Screws are indicated for use in non-spinal fracture and fragment fixation, osteotomy and arthrodesis of human bones appropriate for the size of the screw. The devices are intended for single use only. The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday)…
Read the full statement (162 words)
Cannulated Headless Bone Screws
The aap Cannulated Headless Bone Screws are indicated for use in non-spinal fracture and fragment fixation, osteotomy and arthrodesis of human bones appropriate for the size of the screw. The devices are intended for single use only. The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
K-Wire
K-Wires are indicated for use as guide wire for osteosynthesis implants and for application as implant according to the AO/ASIF principles of fracture management.
The K-Wires are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233008: Cannulated Headless Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233008
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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