510(k) · Cleared
ClearedAPTUS Wrist 2.5 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 Jun 9, 2015 as substantially equivalent to K051567 (Medartis, Inc., 2005) and 3 other predicates after a 246-day review. Its family tree reaches back 6 generations to 1996. 59 later devices descend from it.
- Decided
- Jun 9, 2015
- Review
- 246 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K962616 (1996). 20 ancestors in all, the oldest K885250 (1989). 59 later devices descend from it, 16 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 backK103332 Aptus Ulna PlatesMedartis AG · 2011
- This deviceK142906 APTUS Wrist 2.5 SystemMedartis AG · 2015
- Descendant · cites it directly · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · cites it directly · 8 of its ownK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
- Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
- K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022 · cites it directly8descendants
- K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
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 | K103332 | Aptus Ulna Plates | Medartis AG | 2011 | — |
| 0 (this device) | K142906 | APTUS Wrist 2.5 System | Medartis AG | 2015 | — |
| +1 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +1 | K213864 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | 2022 | — |
| +2 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 13 | 0 |
| 2025 | 9 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K051567 | Aptus Titanium Osteosynthesis SystemSummary page 5…arthrodeses. DEVICE DESCRIPTION APTUS Wrist 2.5 System consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and non-locking. This submission includes additional lengths of non-locking screws. Plates have a low overall heig… | 2005 |
| * | K103332 | Aptus Ulna PlatesSummary page 5…otomies and arthrodeses. DEVICE DESCRIPTION APTUS Wrist 2.5 System consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and non-locking. This submission includes additional lengths of non-locking screws. Plates have a low… | 2011 |
| * | K040022 | Stryker Leibinger Universal Distal Radius SystemSummary page 5…n indications and design principles to the following predicate devices: K051567, APTUS® Titanium Fixation System, Medartis, Inc. K103332, APTUS® Ulna Plates, Medartis AG K040022, Stryker® Leibinger Universal Distal Radius System, Stryker Leibinger K070946, Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Vola… | 2004 |
| * | K070946 | Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius PlatesSummary page 5…7, APTUS® Titanium Fixation System, Medartis, Inc. K103332, APTUS® Ulna Plates, Medartis AG K040022, Stryker® Leibinger Universal Distal Radius System, Stryker Leibinger K070946, Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plate, Synthes (USA) The subject device and the predicate dev… | 2007 |
What descends from it? (59)
See all 5916 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163361 | ANTHEM™ Fracture System | 2017 | 14 |
| K213864 | Bonebridge Osteosynthesis Plating System | 2022 | 8 |
| K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System | 2020 | 8 |
| K172170 | APTUS (R) Wrist 2.5 System | 2017 | 8 |
| K151468 | ARIX Wrist System | 2016 | 7 |
| K222624 | KLS Martin LINOS Wrist System | 2023 | 5 |
| K223853 | Medartis APTUS® Ulna Plates | 2023 | 5 |
| K182718 | Mini and Micro Fragments Reconstruction System – GMReis | 2019 | 4 |
| K232144 | Sterile Products of the APTUS System | 2023 | 3 |
| K191848 | APTUS Wrist Spanning Plates 2.5 | 2019 | 2 |
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 19 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K163361 (Globus Medical, Inc., 2017) has gone furthest, with 14 descendants of its own.
- 21 other devices also cite its predicate K051567.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142906 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142906: APTUS Wrist 2.5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142906
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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