510(k) · Cleared
ClearedTITAN Nail; 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 Apr 17, 2026 as substantially equivalent to K232251 (Medartis AG, 2023) and 1 other predicate after a 28-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Apr 17, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K962823 (1996). 81 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK133460 Aptus Cannulated Compression ScrewsMedartis AG · 2013
- 2 generations backK202589 APTUS Cannulated Compression Screws, APTUS headed Cannulated…Medartis AG · 2020 · Recalled
- 1 generation backK232251 APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire…Medartis AG · 2023
- This deviceK260934 TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026
Show all 10 generations
- Root · 10 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 9 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 8 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 7 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 6 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 5 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 4 generations backK110658 Aptus Cannulated Compression ScrewsMedartis AG · 2011
- 3 generations backK133460 Aptus Cannulated Compression ScrewsMedartis AG · 2013
- 2 generations backK202589 APTUS Cannulated Compression Screws, APTUS headed Cannulated…Medartis AG · 2020 · Recalled
- 1 generation backK232251 APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire…Medartis AG · 2023
- This deviceK260934 TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −9 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −8 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −7 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −6 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −5 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −4 | K110658 | Aptus Cannulated Compression Screws | Medartis AG | 2011 | — |
| −3 | K133460 | Aptus Cannulated Compression Screws | Medartis AG | 2013 | — |
| −2 | K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression… | Medartis AG | 2020 | 1 |
| −1 | K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line… | Medartis AG | 2023 | — |
| 0 (this device) | 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 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 9 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 8 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionSummary page 5…3040 Product Code(s) HWC, HTY | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K232251 APTUS Cannulated Compression Screws HWC K202589 APTUS K-Wire System HTY Device Description Summary 21 CFR 807.92(a)(4) The purpo… | 2023 |
| * | K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Summary page 5…d Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K232251 APTUS Cannulated Compression Screws HWC K202589 APTUS K-Wire System HTY Device Description Summary 21 CFR 807.92(a)(4) The purpose of this submission is to obtain marketing cle… | 2020 |
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 30 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 15 of the 81 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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, including TITAN Nails, are indicated 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/K260934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260934: TITAN Nail; 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/K260934
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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