510(k) · Cleared
Recalled · Class II · 2026APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
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 Nov 6, 2020 as substantially equivalent to K133460 (Medartis AG, 2013) and 4 other predicates after a 59-day review. Its family tree reaches back 8 generations to 1996. 6 later devices descend from it. It has been recalled once.
- Decided
- Nov 6, 2020
- Review
- 59 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 8 generations to K962823 (1996). 49 ancestors in all, the oldest K792022 (1979). 6 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 7 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 6 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 5 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 4 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 3 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 2 generations backK110658 Aptus Cannulated Compression ScrewsMedartis AG · 2011
- 1 generation backK133460 Aptus Cannulated Compression ScrewsMedartis AG · 2013
- This deviceK202589 APTUS Cannulated Compression Screws, APTUS headed Cannulated…Medartis AG · 2020
- Descendant · cites it directly · 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 · 2 generations on · 1 of its ownK230749 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK260934 TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026
- Descendant · 2 generations on · 0 of its ownK234040 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2024 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021 · cites it directly2descendants
- K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG · 2023 · cites it directly1descendant
- K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023 · 2 generations on1descendant
- K260934TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026 · cites it directly0descendants
- K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −7 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −6 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −5 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −4 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −3 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −2 | K110658 | Aptus Cannulated Compression Screws | Medartis AG | 2011 | — |
| −1 | K133460 | Aptus Cannulated Compression Screws | Medartis AG | 2013 | — |
| 0 (this device) | K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression… | Medartis AG | 2020 | — |
| +1 | 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 | — |
| +2 | K230749 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2023 | — |
| +1 | K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026 | — |
| +2 | K234040 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2024 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2005 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K133460 | Aptus Cannulated Compression ScrewsSummary page 6…ulators and Fracture Fixation Devices Team 510(k) Summary K202589 - Page 2 of 4 PREDICATE DEVICE INFORMATION Primary Predicate K133460, APTUS® Cannulated Compression Screws, Medartis AG Additional Predicates K110658, APTUS® Cannulated Compression Screws, Medarti… | 2013 |
| * | K110658 | Aptus Cannulated Compression ScrewsSummary page 6…0(k) Summary K202589 - Page 2 of 4 PREDICATE DEVICE INFORMATION Primary Predicate K133460, APTUS® Cannulated Compression Screws, Medartis AG Additional Predicates K110658, APTUS® Cannulated Compression Screws, Medartis AG K092038, APTUS® K-Wire System, Medartis AG K050681, Omnitech System & Easy L… | 2011 |
| * | K092038 | Aptus K-Wire SystemSummary page 6…MATION Primary Predicate K133460, APTUS® Cannulated Compression Screws, Medartis AG Additional Predicates K110658, APTUS® Cannulated Compression Screws, Medartis AG K092038, APTUS® K-Wire System, Medartis AG K050681, Omnitech System & Easy Lock Osteosystem with Xtremities Plates, TriMed, Inc. K96319… | 2009 |
| * | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities PlatesSummary page 6…annulated Compression Screws, Medartis AG Additional Predicates K110658, APTUS® Cannulated Compression Screws, Medartis AG K092038, APTUS® K-Wire System, Medartis AG K050681, Omnitech System & Easy Lock Osteosystem with Xtremities Plates, TriMed, Inc. K963192, Synthes Sterile 3.5 mm and 4.0 mm Cannula… | 2005 |
| * | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSummary page 6…lated Compression Screws, Medartis AG K092038, APTUS® K-Wire System, Medartis AG K050681, Omnitech System & Easy Lock Osteosystem with Xtremities Plates, TriMed, Inc. K963192, Synthes Sterile 3.5 mm and 4.0 mm Cannulated Screws, Synthes (USA) Reference Devices K193633, APTUS Ankle Trauma System 2.8/3.… | 1996 |
| † | K193633 | APTUS® Ankle Trauma System 2.8/3.5 | 2020 |
| † | K191848 | APTUS Wrist Spanning Plates 2.5 | 2019 |
What descends from it? (6)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2026 | Class II | Z-2361-2026 | Under Investigation by firm | The cannulation of the CCS screw is not centered. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 8 of the 49 ancestors have a recall of any class.
- Of its descendants, K211783 (TriMed, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K133460.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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® Cannulated Compression Screws and headed Cannulated Compression Screws are intended for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size.
APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.
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/K202589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202589: APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202589
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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