510(k) · Cleared
ClearedAPTUS® Foot 2.8-3.5 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medartis AG · HRS Plate, Fixation, Bone
Cleared on Mar 26, 2020 as substantially equivalent to K091479 (Medartis AG, 2009) and 3 other predicates after a 90-day review. Its family tree reaches back 6 generations to 2000. 9 later devices descend from it.
- Decided
- Mar 26, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K000684 (2000). 16 ancestors in all, the oldest K890939 (1989). 9 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 4 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 3 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 2 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 1 generation backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- This deviceK193639 APTUS® Foot 2.8-3.5 SystemMedartis AG · 2020
- Descendant · cites it directly · 4 of its ownK240613 APTUS Elbow Dorsal Olecranon PlatesMedartis AG · 2024
- Descendant · 2 generations on · 2 of its ownK243610 APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
- Descendant · cites it directly · 2 of its ownK230971 APTUS® 3.5 TriLock Straight PlatesMedartis AG · 2023
- Descendant · 2 generations on · 1 of its ownK232251 APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire…Medartis AG · 2023
- Descendant · 3 generations on · 0 of its ownK260761 APTUS Clavicle System 2.8Medartis AG · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG · 2024 · cites it directly4descendants
- K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025 · 2 generations on2descendants
- K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG · 2023 · cites it directly2descendants
- K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG · 2023 · 2 generations on1descendant
- K260761APTUS Clavicle System 2.8Medartis AG · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −5 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −4 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −3 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −2 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −1 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K193639 | APTUS® Foot 2.8-3.5 System | Medartis AG | 2020 | — |
| +1 | K240613 | APTUS Elbow Dorsal Olecranon Plates | Medartis AG | 2024 | — |
| +2 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | 2025 | — |
| +1 | K230971 | APTUS® 3.5 TriLock Straight Plates | Medartis AG | 2023 | — |
| +2 | K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line… | Medartis AG | 2023 | — |
| +3 | K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K091479 | Aptus Foot SystemSummary page 4…on Division of Health Technology 6 C (Restorative, Repair and Trauma Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K091479, APTUS® Foot System, Medartis AG Additional Predicates K061808, DARCO Locking Bone Plate System, DARCO International, Inc. K0526… | 2009 |
| * | K061808 | Darco Locking Bone Plate SystemSummary page 4…(Restorative, Repair and Trauma Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K091479, APTUS® Foot System, Medartis AG Additional Predicates K061808, DARCO Locking Bone Plate System, DARCO International, Inc. K052614, Arthrex Low Profile Plate and Screw System, Arthrex, Inc. K0… | 2006 |
| * | K052614 | Low Profile Plate and Screw SystemSummary page 4…INFORMATION Primary Predicate Device K091479, APTUS® Foot System, Medartis AG Additional Predicates K061808, DARCO Locking Bone Plate System, DARCO International, Inc. K052614, Arthrex Low Profile Plate and Screw System, Arthrex, Inc. K000684, Small Fragment Dynamic Compression Locking (DCL) System, Synt… | 2005 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 4…Medartis AG Additional Predicates K061808, DARCO Locking Bone Plate System, DARCO International, Inc. K052614, Arthrex Low Profile Plate and Screw System, Arthrex, Inc. K000684, Small Fragment Dynamic Compression Locking (DCL) System, Synthes (USA) 510(k) Summary… | 2000 |
| † | K191848 | APTUS Wrist Spanning Plates 2.5 | 2019 |
| † | K181425 | APTUS® Proximal Humerus System | 2018 |
| † | K110908 | Aptus Foot 3.5 System | 2011 |
What descends from it? (9)
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 20 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 16 ancestors have a recall of any class.
- Of its descendants, K240613 (Medartis AG, 2024) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K091479.
How does its category compare?
All HRS devicesHRS Plate, 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 · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The APTUS® Foot 2.8-3.5 System is intended for use in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193639: APTUS® Foot 2.8-3.5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193639
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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