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 Dec 18, 2013 as substantially equivalent to K092038 (Medartis AG, 2009) and 4 other predicates after a 36-day review. Its family tree reaches back 7 generations to 1996. 8 later devices descend from it.
- Decided
- Dec 18, 2013
- Review
- 36 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K962823 (1996). 29 ancestors in all, the oldest K792022 (1979). 8 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 6 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 5 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 4 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 3 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 2 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 1 generation backK110658 Aptus Cannulated Compression ScrewsMedartis AG · 2011
- This deviceK133460 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 · 3 generations on · 1 of its ownK230749 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK260934 TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- 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
- K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023 · 3 generations on1descendant
- K260934TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −6 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −5 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −4 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −3 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −2 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −1 | K110658 | Aptus Cannulated Compression Screws | Medartis AG | 2011 | — |
| 0 (this device) | 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 | — |
| +3 | K230749 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2023 | — |
| +2 | K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 4 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K092038 | Aptus K-Wire SystemSummary page 2…ompression Screws 5.0, 7.0 are substantially equivalent in indications and design principles to the following predicate devices: * Medartis AG, APTUS®'K-Wire System (K092038) * Medartis AG, APTUS® Cannulated Compression Screws (Ki 10658) " Synthes (USA), Synthes 4.5 mm and 6.5 mm Headless Compr… | 2009 |
| * | K110658 | Aptus Cannulated Compression Screws | 2011 |
| * | K080943 | Synthes 4.5 MM and 6.5 MM Headless Compression ScrewsSummary page 2…S®'K-Wire System (K092038) * Medartis AG, APTUS® Cannulated Compression Screws (Ki 10658) " Synthes (USA), Synthes 4.5 mm and 6.5 mm Headless Compression Screws (K080943) * Synthes (USA), Synthes 7.0/7.3 mm Cannulated Screws (K96201 1) * Wright Medical Technology, Inc., DARCOO' Headless C… | 2008 |
| * | K962011 | Synthes 7.0/7.3 MM Cannulated ScrewsSummary page 2…ession Screws (Ki 10658) " Synthes (USA), Synthes 4.5 mm and 6.5 mm Headless Compression Screws (K080943) * Synthes (USA), Synthes 7.0/7.3 mm Cannulated Screws (K96201 1) * Wright Medical Technology, Inc., DARCOO' Headless Compression Screw (KOXOSSO) APTUS® Cannulated Compression Screws 5.0,… | 1996 |
| * | K080850 | Darco Headless Compression ScrewSummary page 2…ns and identical materials as those cleared under K092038 and KI 10658. The subject device is similar in indications to those cleared in KI 10658, K080943, K96201 1, and K080850. The designs and dimensions of the subject device are similar and within the range of those cleared in K080943, K96201 1, and K08… | 2008 |
What descends from it? (8)
3 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 17 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K202589 (Medartis AG, 2020) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K092038.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 5.0, 7.0 are intended for the treatment of fractures, osteotomies and arthrodeses of bones with the appropriate screw size.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133460: 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/K133460
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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