510(k) · Cleared
ClearedAptus Cannulated Compression Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medartis AG · HWC Screw, Fixation, Bone
Cleared on Jun 2, 2011 as substantially equivalent to K021556 (Synthes (Usa), 2002) and 5 other predicates after an 87-day review. Its family tree reaches back 6 generations to 1996. 12 later devices descend from it.
- Decided
- Jun 2, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K962823 (1996). 24 ancestors in all, the oldest K792022 (1979). 12 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 4 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 3 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 2 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 1 generation backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- This deviceK110658 Aptus Cannulated Compression ScrewsMedartis AG · 2011
- Descendant · cites it directly · 8 of its ownK133460 Aptus Cannulated Compression ScrewsMedartis AG · 2013
- Descendant · cites it directly · 6 of its ownK202589 APTUS Cannulated Compression Screws, APTUS headed Cannulated…Medartis AG · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK211783 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK232251 APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire…Medartis AG · 2023
- Descendant · cites it directly · 1 of its ownK230744 Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K133460Aptus Cannulated Compression ScrewsMedartis AG · 2013 · cites it directly8descendants
- K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG · 2020 · cites it directly6descendants
- K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021 · 2 generations on2descendants
- K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG · 2023 · cites it directly1descendant
- K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −5 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −4 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −3 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −2 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −1 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| 0 (this device) | K110658 | Aptus Cannulated Compression Screws | Medartis AG | 2011 | — |
| +1 | K133460 | Aptus Cannulated Compression Screws | Medartis AG | 2013 | — |
| +1 | K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression… | Medartis AG | 2020 | 1 |
| +2 | K211783 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2021 | — |
| +1 | K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line… | Medartis AG | 2023 | — |
| +1 | K230744 | Acumed Acutrak 3 Headless Compression Screw System | Acumed, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 4 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (6)
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 |
|---|---|---|---|
| * | K021556 | Synthes 2.4 MM Cannulated Compression ScrewSummary page 2…s been determined by FDA to be substantially equivalent to pre-amendment devices: Synthes (USA), Synthes (USA) 2.4 mm Cannulated Compression Screw, cleared under K02 1556; Synthes (USA), Synthes (USA) 3.0 mm Headless Compression Screws, cleared under K050636; OsteoMed L.P., OsteoMed Head… | 2002 |
| * | K050636 | Synthes 3.0MM Headless Compression ScrewsSummary page 2…A), Synthes (USA) 2.4 mm Cannulated Compression Screw, cleared under K02 1556; Synthes (USA), Synthes (USA) 3.0 mm Headless Compression Screws, cleared under K050636; OsteoMed L.P., OsteoMed Headless Cannulated Screw System, cleared under K063298; Wright Medical Technology, Inc., CHARLO… | 2005 |
| * | K063298 | Osteomed Headless Cannulated Screw SystemSummary page 2…Synthes (USA), Synthes (USA) 3.0 mm Headless Compression Screws, cleared under K050636; OsteoMed L.P., OsteoMed Headless Cannulated Screw System, cleared under K063298; Wright Medical Technology, Inc., CHARLOTTEIm 7.0 MUC Screw and Washer, cleared under K070525; Wright Medical Technol… | 2007 |
| * | K070525 | Charlotte 7.0 Multi-Use Compression Screw and WasherSummary page 2…oMed L.P., OsteoMed Headless Cannulated Screw System, cleared under K063298; Wright Medical Technology, Inc., CHARLOTTEIm 7.0 MUC Screw and Washer, cleared under K070525; Wright Medical Technology, Inc., CHARLOTTETM High Demand Compression Screw, cleared under K043281; and Howmedica Ost… | 2007 |
| * | K043281 | Charlotte High-Demand Compression ScrewSummary page 2…Inc., CHARLOTTEIm 7.0 MUC Screw and Washer, cleared under K070525; Wright Medical Technology, Inc., CHARLOTTETM High Demand Compression Screw, cleared under K043281; and Howmedica Osteonics Corporation (now Stryker Corporation), AsniSTM III Cannulated Screw System, cleared under K07 10… | 2005 |
| * | K071092 | Asnis Micro Cannulated ScrewSummary page 2…d Compression Screw, cleared under K043281; and Howmedica Osteonics Corporation (now Stryker Corporation), AsniSTM III Cannulated Screw System, cleared under K07 1092. APTUS Cannulated Compression Screws and the predicate devices are all compression screws having similar indications for use and… | 2007 |
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133460 | Aptus Cannulated Compression Screws | 2013 | 8 |
| K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS… | 2020 | 6 |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | 2023 | 1 |
| K230744 | Acumed Acutrak 3 Headless Compression Screw System | 2023 | 1 |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | 2022 | 0 |
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 15 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 24 ancestors have a recall of any class.
- Of its descendants, K133460 (Medartis AG, 2013) has gone furthest, with 8 descendants of its own.
- 9 other devices also cite its predicate K021556.
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?
APTUS® Canulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodeses of bones e.g. in the hand, wrist, elbow, foot with the appropriate screw size.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110658: Aptus Cannulated Compression Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110658
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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