510(k) · Cleared
ClearedAPTUS Wrist Arthrodesis Plates
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 Nov 8, 2019 as substantially equivalent to K112169 (Medartis AG, 2012) after a 77-day review. Its family tree reaches back 6 generations to 1996. 7 later devices descend from it.
- Decided
- Nov 8, 2019
- Review
- 77 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962616 (1996). 22 ancestors in all, the oldest K885250 (1989). 7 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 4 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 3 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 1 generation backK112169 Aptus Wrist Arthrodesis PlatesMedartis AG · 2012
- This deviceK192297 APTUS Wrist Arthrodesis PlatesMedartis AG · 2019
- Descendant · cites it directly · 5 of its ownK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023
- Descendant · 2 generations on · 3 of its ownK234062 APTUS Hand Scaphoid PlatesMedartis AG · 2024
- Descendant · cites it directly · 3 of its ownK232144 Sterile Products of the APTUS SystemMedartis AG · 2023
- Descendant · 2 generations on · 2 of its ownK243610 APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
- Descendant · 3 generations on · 0 of its ownK260761 APTUS Clavicle System 2.8Medartis AG · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K223853Medartis APTUS® Ulna PlatesMedartis AG · 2023 · cites it directly5descendants
- K234062APTUS Hand Scaphoid PlatesMedartis AG · 2024 · 2 generations on3descendants
- K232144Sterile Products of the APTUS SystemMedartis AG · 2023 · cites it directly3descendants
- K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025 · 2 generations on2descendants
- 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 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −5 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −4 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −3 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −1 | K112169 | Aptus Wrist Arthrodesis Plates | Medartis AG | 2012 | — |
| 0 (this device) | K192297 | APTUS Wrist Arthrodesis Plates | Medartis AG | 2019 | — |
| +1 | K223853 | Medartis APTUS® Ulna Plates | Medartis AG | 2023 | — |
| +2 | K234062 | APTUS Hand Scaphoid Plates | Medartis AG | 2024 | — |
| +1 | K232144 | Sterile Products of the APTUS System | Medartis AG | 2023 | — |
| +2 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | 2025 | — |
| +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 |
| 1992 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K112169 | Aptus Wrist Arthrodesis PlatesSummary page 4…Division of Health Technology 6 C (Restorative, Repair and Trauma Devices) PREDICATE DEVICE INFORMATION The primary predicate device is K112169, APTUS® Wrist Arthrodesis Plates, Medartis AG. The reference devices are: K142906, APTUS® Wrist 2.5 System, Medartis AG; K042355… | 2012 |
| † | K142906 | APTUS Wrist 2.5 System | 2015 |
| † | K042355 | Synthes (Usa) LCP Wrist Fusion Plates | 2004 |
| † | K051567 | Aptus Titanium Osteosynthesis System | 2005 |
What descends from it? (7)
2 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 23 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K223853 (Medartis AG, 2023) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192297 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192297: APTUS Wrist Arthrodesis Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192297
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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