510(k) · Cleared
ClearedAPTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
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 3, 2023 as substantially equivalent to K202589 (Medartis AG, 2020) and 5 other predicates after a 98-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Nov 3, 2023
- Review
- 98 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K962823 (1996). 80 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK110658 Aptus Cannulated Compression ScrewsMedartis AG · 2011
- 2 generations backK133460 Aptus Cannulated Compression ScrewsMedartis AG · 2013
- 1 generation backK202589 APTUS Cannulated Compression Screws, APTUS headed Cannulated…Medartis AG · 2020 · Recalled
- This deviceK232251 APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire…Medartis AG · 2023
- Descendant · cites it directly · 0 of its ownK260934 TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026
Show all 9 generations
- Root · 9 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 8 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 7 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 6 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 5 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 4 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 3 generations backK110658 Aptus Cannulated Compression ScrewsMedartis AG · 2011
- 2 generations backK133460 Aptus Cannulated Compression ScrewsMedartis AG · 2013
- 1 generation backK202589 APTUS Cannulated Compression Screws, APTUS headed Cannulated…Medartis AG · 2020 · Recalled
- This deviceK232251 APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire…Medartis AG · 2023
Most influential descendants
Showing 1 of 1 · See all- K260934TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −8 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −7 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −6 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −5 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −4 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −3 | K110658 | Aptus Cannulated Compression Screws | Medartis AG | 2011 | — |
| −2 | K133460 | Aptus Cannulated Compression Screws | Medartis AG | 2013 | — |
| −1 | K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression… | Medartis AG | 2020 | 1 |
| 0 (this device) | K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line… | Medartis AG | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Summary page 6…2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) PREDICATE DEVICE INFORMATION Primary Predicate Device K202589, APTUS® headed Cannulated Compression Screws, APTUS® Cannulated Compression Screws, APTUS® K-Wire System, Medartis AG Additional… | 2020 |
| * | K133460 | Aptus Cannulated Compression ScrewsSummary page 6…dicate Device K202589, APTUS® headed Cannulated Compression Screws, APTUS® Cannulated Compression Screws, APTUS® K-Wire System, Medartis AG Additional Predicate Devices K133460, APTUS Cannulated Compression Screws 5.0,7.0, Medartis AG K110658, APTUS® Cannulated Compression Screws, Medartis AG K092038, APT… | 2013 |
| * | K110658 | Aptus Cannulated Compression ScrewsSummary page 6…, APTUS® Cannulated Compression Screws, APTUS® K-Wire System, Medartis AG Additional Predicate Devices K133460, APTUS Cannulated Compression Screws 5.0,7.0, Medartis AG K110658, APTUS® Cannulated Compression Screws, Medartis AG K092038, APTUS® K-Wire System, Medartis AG K230971, APTUS 3.5 TriLock Straight… | 2011 |
| * | K092038 | Aptus K-Wire SystemSummary page 6…m, Medartis AG Additional Predicate Devices K133460, APTUS Cannulated Compression Screws 5.0,7.0, Medartis AG K110658, APTUS® Cannulated Compression Screws, Medartis AG K092038, APTUS® K-Wire System, Medartis AG K230971, APTUS 3.5 TriLock Straight Plates, Medartis AG K963192, Synthes Sterile 3.5 mm and 4.… | 2009 |
| * | K230971 | APTUS® 3.5 TriLock Straight PlatesSummary page 6…s K133460, APTUS Cannulated Compression Screws 5.0,7.0, Medartis AG K110658, APTUS® Cannulated Compression Screws, Medartis AG K092038, APTUS® K-Wire System, Medartis AG K230971, APTUS 3.5 TriLock Straight Plates, Medartis AG K963192, Synthes Sterile 3.5 mm and 4.0 mm Cannulated Screws, Synthese (USA) IND… | 2023 |
| * | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSummary page 6…Medartis AG K110658, APTUS® Cannulated Compression Screws, Medartis AG K092038, APTUS® K-Wire System, Medartis AG K230971, APTUS 3.5 TriLock Straight Plates, Medartis AG K963192, Synthes Sterile 3.5 mm and 4.0 mm Cannulated Screws, Synthese (USA) INDICATIONS FOR USE STATEMENT APTUS® Cannulated Compression… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260934 | TITAN Nail; APTUS K-Wire System | 2026 | 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 27 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 15 of the 80 ancestors have a recall of any class.
- Of its descendants, K260934 (Medartis AG, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K202589.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 indicated for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size in the shoulder, elbow, wrist, hand, knee, and the foot and ankle.
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 as stated in the FDA summary.
https://510kreport.com/device/K232251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232251: APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232251
Report an extraction error
Are you the manufacturer?
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