510(k) · Cleared
ClearedAptus Proximal Humerus 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 Apr 27, 2012 as substantially equivalent to K011815 (Synthes (Usa), 2001) and 2 other predicates after a 105-day review. Its family tree reaches back 4 generations to 2004. 2 later devices descend from it.
- Decided
- Apr 27, 2012
- Review
- 105 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K042059 (2004). 6 ancestors in all, the oldest K011815 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK042059 Shoulder Fixation SystemHand Innovations, Inc. · 2004
- 3 generations backK051728 Modification to Shoulder Fixation SystemHand Innovations, LLC · 2005
- 2 generations backK060290 Shoulder Fixation SystemHand Innovations, LLC · 2006
- 1 generation backK093978 Exactech Equinoxe Proximal Humerus Fracture Plate SystemExactech, Inc. · 2010
- This deviceK120108 Aptus Proximal Humerus SystemMedartis AG · 2012
- Descendant · cites it directly · 1 of its ownK181425 APTUS® Proximal Humerus SystemMedartis AG · 2018
- Descendant · cites it directly · 0 of its ownK253916 APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042059 | Shoulder Fixation System | Hand Innovations, Inc. | 2004 | — |
| −3 | K051728 | Modification to Shoulder Fixation System | Hand Innovations, LLC | 2005 | — |
| −2 | K060290 | Shoulder Fixation System | Hand Innovations, LLC | 2006 | — |
| −1 | K093978 | Exactech Equinoxe Proximal Humerus Fracture Plate System | Exactech, Inc. | 2010 | — |
| 0 (this device) | K120108 | Aptus Proximal Humerus System | Medartis AG | 2012 | — |
| +1 | K181425 | APTUS® Proximal Humerus System | Medartis AG | 2018 | — |
| +1 | K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K011815 | Synthes LCP Proximal Humerus Plates | 2001 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 2…device: Synthes (USA), Synthes LCP Proximal Humerus Plate, cleared under KOI 1815; Synthes (USA), Synthes (USA) LCP® Proximal Humerus Plates, long, cleared under K041860; and Exactech, Inc., Exactech®Equinoxe®Proximal Humerus Fracture Plate System, cleared under K093978. The subject device an… | 2004 |
| * | K093978 | Exactech Equinoxe Proximal Humerus Fracture Plate SystemSummary page 2…nthes (USA) LCP® Proximal Humerus Plates, long, cleared under K041860; and Exactech, Inc., Exactech®Equinoxe®Proximal Humerus Fracture Plate System, cleared under K093978. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The su… | 2010 |
What descends from it? (2)
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 8 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K181425 (Medartis AG, 2018) has gone furthest, with 1 descendant of its own.
- 24 other devices also cite its predicate K011815.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120108: Aptus Proximal Humerus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120108
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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