510(k) · Cleared
ClearedAptus (R) Distal 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 Dec 15, 2011 as substantially equivalent to K091479 (Medartis AG, 2009) and 3 other predicates after a 104-day review. Its family tree reaches back 8 generations to 1996. 8 later devices descend from it.
- Decided
- Dec 15, 2011
- Review
- 104 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K962616 (1996). 27 ancestors in all, the oldest K885250 (1989). 8 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 3 generations backK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
- 2 generations backK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
- 1 generation backK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
- This deviceK112560 Aptus (R) Distal Humerus SystemMedartis AG · 2011
- Descendant · cites it directly · 6 of its ownK171285 ARIX Diaphysis SystemJeil Medical Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK172008 ARIX Humerus SystemJeil Medical Corporation · 2017
- Descendant · 3 generations on · 1 of its ownK202912 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020
- Descendant · 2 generations on · 1 of its ownK180972 ARIX Clavicle SystemJeil Medical Corporation · 2018
- Descendant · 4 generations on · 0 of its ownK232115 TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K171285ARIX Diaphysis SystemJeil Medical Corporation · 2017 · cites it directly6descendants
- K172008ARIX Humerus SystemJeil Medical Corporation · 2017 · 2 generations on3descendants
- K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020 · 3 generations on1descendant
- K180972ARIX Clavicle SystemJeil Medical Corporation · 2018 · 2 generations on1descendant
- K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −3 | K062498 | Profyle System | Howmedica Osteonics Corp. | 2006 | 1 |
| −2 | K073527 | Variax Elbow System | Howmedica Osteonics Corp. | 2008 | — |
| −1 | K101056 | Variax Elbow System | Howmedica Osteonics Corp. | 2010 | — |
| 0 (this device) | K112560 | Aptus (R) Distal Humerus System | Medartis AG | 2011 | — |
| +1 | K171285 | ARIX Diaphysis System | Jeil Medical Corporation | 2017 | — |
| +2 | K172008 | ARIX Humerus System | Jeil Medical Corporation | 2017 | — |
| +3 | K202912 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2020 | — |
| +2 | K180972 | ARIX Clavicle System | Jeil Medical Corporation | 2018 | — |
| +4 | K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 2…g predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: Medartis AG, APTUS® Foot System, cleared under K09 1479; Medartis AG, APTUS® Ulna Plates, cleared under K103332; Synthes (USA), Synthes (USA) 3.5 mm LCP Distal Humerus System, c… | 2009 |
| * | K103332 | Aptus Ulna PlatesSummary page 2…to be substantially equivalent to pre-amendment devices: Medartis AG, APTUS® Foot System, cleared under K09 1479; Medartis AG, APTUS® Ulna Plates, cleared under K103332; Synthes (USA), Synthes (USA) 3.5 mm LCP Distal Humerus System, cleared under K033995; and Howmedica Osteonics Corp.,… | 2011 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 2…cleared under K09 1479; Medartis AG, APTUS® Ulna Plates, cleared under K103332; Synthes (USA), Synthes (USA) 3.5 mm LCP Distal Humerus System, cleared under K033995; and Howmedica Osteonics Corp., VariAx Elbow System, cleared under K101056. The subject device and the predicate devices have… | 2004 |
| * | K101056 | Variax Elbow SystemSummary page 2…3332; Synthes (USA), Synthes (USA) 3.5 mm LCP Distal Humerus System, cleared under K033995; and Howmedica Osteonics Corp., VariAx Elbow System, cleared under K101056. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The sub… | 2010 |
What descends from it? (8)
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 15 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 27 ancestors have a recall of any class.
- Of its descendants, K171285 (Jeil Medical Corporation, 2017) has gone furthest, with 6 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. 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?
APTUSO Distal FHumeruLs System is indicated for fractures, osteotomies and non-unions of the distal humeuLs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112560: Aptus (R) Distal Humerus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112560
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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