510(k) · Cleared
ClearedAptus Ulna 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 Jan 24, 2011 as substantially equivalent to K051567 (Medartis, Inc., 2005) and 3 other predicates after a 73-day review. Its family tree reaches back 5 generations to 1996. 71 later devices descend from it.
- Decided
- Jan 24, 2011
- Review
- 73 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K962616 (1996). 18 ancestors in all, the oldest K885250 (1989). 71 later devices descend from it, 12 citing it directly.
- Root · 5 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 4 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 3 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 2 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 1 generation backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- This deviceK103332 Aptus Ulna PlatesMedartis AG · 2011
- Descendant · cites it directly · 59 of its ownK142906 APTUS Wrist 2.5 SystemMedartis AG · 2015
- Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K142906APTUS Wrist 2.5 SystemMedartis AG · 2015 · cites it directly59descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 3 generations on10descendants
- K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −4 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −3 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −2 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −1 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| 0 (this device) | K103332 | Aptus Ulna Plates | Medartis AG | 2011 | — |
| +1 | K142906 | APTUS Wrist 2.5 System | Medartis AG | 2015 | — |
| +2 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +3 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +3 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +2 | K213864 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | 2022 | — |
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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 8 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 13 | 0 |
| 2025 | 10 | 0 |
| 2026 | 11 | 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 2…g predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: APTUS® Titanium Fixation System cleared under K051567, APTUS® K-Wire cleared under K092038, Synthes USA, Synthes (USA) Modular Mini Fragment LCP System, cleared under K… | 2005 |
| * | K092038 | Aptus K-Wire SystemSummary page 2…n determined by FDA to be substantially equivalent to pre-amendment devices: APTUS® Titanium Fixation System cleared under K051567, APTUS® K-Wire cleared under K092038, Synthes USA, Synthes (USA) Modular Mini Fragment LCP System, cleared under K063049, The Synthes (USA) 3.5 / 4.5 m… | 2009 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 2…ium Fixation System cleared under K051567, APTUS® K-Wire cleared under K092038, Synthes USA, Synthes (USA) Modular Mini Fragment LCP System, cleared under K063049, The Synthes (USA) 3.5 / 4.5 mm LCP Metaphyseal Plates, cleared under K033805. The subject device and the predicate devices… | 2006 |
| * | K033805 | Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal PlatesSummary page 2…, Synthes USA, Synthes (USA) Modular Mini Fragment LCP System, cleared under K063049, The Synthes (USA) 3.5 / 4.5 mm LCP Metaphyseal Plates, cleared under K033805. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The su… | 2004 |
What descends from it? (71)
See all 7112 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142906 | APTUS Wrist 2.5 System | 2015 | 59 |
| K112560 | Aptus (R) Distal Humerus System | 2011 | 8 |
| K151468 | ARIX Wrist System | 2016 | 7 |
| K223853 | Medartis APTUS® Ulna Plates | 2023 | 5 |
| K141232 | Aptus Ulna Shortening 2.5 | 2014 | 5 |
| K232144 | Sterile Products of the APTUS System | 2023 | 3 |
| K130008 | Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous… | 2013 | 1 |
| K243469 | Signex | 2025 | 0 |
| K232105 | APTUS Foot System 2.8-3.5 | 2024 | 0 |
| K201962 | Skeletal Dynamics Ulnar Shortening Plating System | 2020 | 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 15 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K142906 (Medartis AG, 2015) has gone furthest, with 59 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. 2011, 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® Ulna Plates are indicated for fractures and osteotomnies, in particular for the ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103332: Aptus Ulna Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103332
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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