510(k) · Cleared
ClearedAap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
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 Apr 29, 1999 after a 51-day review. The FDA summary names its predicate without a number. 1 of the 369 devices in its family, counting itself, has a Class I recall. 368 later devices descend from it.
- Decided
- Apr 29, 1999
- Review
- 51 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
368 later devices descend from it, 7 citing it directly. 1 of the 369 devices in this family, counting this one, has a Class I recall.
- This deviceK990776 Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MMAap Implantate AG · 1999
- Descendant · cites it directly · 338 of its ownK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- Descendant · 2 generations on · 299 of its ownK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- Descendant · 3 generations on · 255 of its ownK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- Descendant · 4 generations on · 251 of its ownK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- Descendant · 5 generations on · 246 of its ownK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
Showing 5 of 368 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 368 · See all- K993762I.CO.S ScrewNew Deal, S.A. · 2000 · cites it directly338descendants
- K024233Kompressor Screw SystemKinetikos Medical, Inc. · 2003 · 2 generations on299descendants
- K040356Kompressor Screw SystemKinetikos Medical, Inc. · 2004 · 3 generations on255descendants
- K060071Nexa Compression ScrewNexa Orthopedics, Inc. · 2006 · 4 generations on251descendants
- K063298Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007 · 5 generations on246descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990776 | Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM | Aap Implantate AG | 1999 | — |
| +1 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| +2 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| +3 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| +4 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| +5 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 9 | 0 |
| 2012 | 7 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 22 | 0 |
| 2016 | 14 | 0 |
| 2017 | 26 | 0 |
| 2018 | 10 | 0 |
| 2019 | 18 | 0 |
| 2020 | 21 | 0 |
| 2021 | 27 | 1 |
| 2022 | 24 | 0 |
| 2023 | 30 | 0 |
| 2024 | 33 | 0 |
| 2025 | 33 | 0 |
| 2026 | 46 | 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? (8)
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 |
|---|---|---|---|
| * | — | aap Bone Screws (Stainless Steel & Titanium) Named without a submission number | |
| * | — | OSTEOTECH Cannulated Screws (including Navicular and Cancellous Cannulated Screws)… Named without a submission number | |
| * | — | SYNTHES Small and Large Cannulated Screw System (Stainless Steel 316L) Named without a submission number | |
| * | — | HOWMEDICA ASNIS II Guided Bone Screws (Stainless Steel 316L) Named without a submission number | |
| * | — | BIODYNAMIC TECHNOLOGIES EZ-Fix™ Cannulated Screw System (Ti 6 Al4 V E.L.1) Named without a submission number | |
| * | — | DePuy Cannulated Bone Screw (Stainless Steel 316 LVM) Named without a submission number | |
| * | — | MECRON Cannulated Bone Screws (Stainless Steel 316L) Named without a submission number | |
| * | — | ZIMMER Magna-Fx & Mini Magna-Fx Cannulated Screw Fixation System (Stainless Steel) Named without a submission number |
What descends from it? (368)
See all 3687 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993762 | I.CO.S Screw | 2000 | 338 |
| K021233 | Aap Cannulated Screws | 2002 | 181 |
| K080101 | Aap Cannulated Screw and Darco Headed Screw | 2008 | 180 |
| K011821 | Modification to the I.C.O.S Screw | 2001 | 56 |
| K061620 | Ifs Cannulated Bone Screw | 2006 | 5 |
| K161703 | LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer | 2016 | 0 |
| K030619 | Odi 7.0MM Cannulated Screw System | 2003 | 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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K993762 (New Deal, S.A., 2000) has gone furthest, with 338 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.
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?
aap's 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.
Specific Indications may include:
- scaphoid fractures and other fractures of the hand
- metatarsal fractures and other fractures of the foot
- malleolar fractures
- ligament fixation of the proximal humerus
- wrist, ankle, shoulder and elbow fractures
- condylar fractures
- fractures of the pelvis and acetabulum
- femoral neck and femoral head fractures
- femoral supracondylar fractures
- tibial plateau fractures
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990776: Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990776
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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