510(k) Report

510(k) · Cleared

Cleared

APTUS® Proximal Humerus System

K181425510(k) TraditionalCleared Aug 5, 201866-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medartis AG · HRS Plate, Fixation, Bone

Cleared on Aug 5, 2018 as substantially equivalent to K120108 (Medartis AG, 2012) and 3 other predicates after a 66-day review. Its family tree reaches back 5 generations to 2004. 1 later device descends from it.

Decided
Aug 5, 2018
Review
66 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K042059 (2004). 9 ancestors in all, the oldest K960385 (1996). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2004: 1 other ancestor1996: 1 other ancestor2001: 1 other ancestor2026: 1 descendant clearedK042059 · Shoulder Fixation System · Hand Innovations, Inc. · 2004K051728 · Modification to Shoulder Fixation System · Hand Innovations, LLC · 2005K060290 · Shoulder Fixation System · Hand Innovations, LLC · 2006K093978 · Exactech Equinoxe Proximal Humerus Fracture Plate System · Exactech, Inc. · 2010K120108 · Aptus Proximal Humerus System · Medartis AG · 20121995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K120108 · Aptus Proximal Humerus System · Medartis AG · 2012K093978 · Exactech Equinoxe Proximal Humerus Fracture Plate System · Exactech, Inc. · 2010K060290 · Shoulder Fixation System · Hand Innovations, LLC · 2006K051728 · Modification to Shoulder Fixation System · Hand Innovations, LLC · 2005K042059 · Shoulder Fixation System · Hand Innovations, Inc. · 2004−50
  1. Root · 5 generations backK042059 Shoulder Fixation SystemHand Innovations, Inc. · 2004
  2. 4 generations backK051728 Modification to Shoulder Fixation SystemHand Innovations, LLC · 2005
  3. 3 generations backK060290 Shoulder Fixation SystemHand Innovations, LLC · 2006
  4. 2 generations backK093978 Exactech Equinoxe Proximal Humerus Fracture Plate SystemExactech, Inc. · 2010
  5. 1 generation backK120108 Aptus Proximal Humerus SystemMedartis AG · 2012
  6. This deviceK181425 APTUS® Proximal Humerus SystemMedartis AG · 2018
  7. Descendant · cites it directly · 0 of its ownK253916 APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K042059Shoulder Fixation SystemHand Innovations, Inc.2004—
−4K051728Modification to Shoulder Fixation SystemHand Innovations, LLC2005—
−3K060290Shoulder Fixation SystemHand Innovations, LLC2006—
−2K093978Exactech Equinoxe Proximal Humerus Fracture Plate SystemExactech, Inc.2010—
−1K120108Aptus Proximal Humerus SystemMedartis AG2012—
0 (this device)K181425APTUS® Proximal Humerus SystemMedartis AG2018—
+1K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200110
200410
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K181425, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K120108Aptus Proximal Humerus System
Summary page 4
…es HRS, HTY, HWC Classification Panel Orthopedic Products Panel PREDICATE DEVICE INFORMATION The primary predicate device is K120108. Additional predicate devices are K041860, K092038, and K960385. INDICATIONS FOR USE STATEMENT APTUS® Proximal Humerus System is…
Medartis AG2012—
*K041860Synthes (Usa) LCP Proximal Humerus Plates, Long
Summary page 4
…Classification Panel Orthopedic Products Panel PREDICATE DEVICE INFORMATION The primary predicate device is K120108. Additional predicate devices are K041860, K092038, and K960385. INDICATIONS FOR USE STATEMENT APTUS® Proximal Humerus System is indicated for fractures, osteotomies and…
Synthes (Usa)2004—
*K092038Aptus K-Wire System
Summary page 4
…cation Panel Orthopedic Products Panel PREDICATE DEVICE INFORMATION The primary predicate device is K120108. Additional predicate devices are K041860, K092038, and K960385. INDICATIONS FOR USE STATEMENT APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-union…
Medartis AG2009—
*K960385Sterile Kirschner Wires and Steinmann Pins
Summary page 4
…Orthopedic Products Panel PREDICATE DEVICE INFORMATION The primary predicate device is K120108. Additional predicate devices are K041860, K092038, and K960385. INDICATIONS FOR USE STATEMENT APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the prox…
Depuy, Inc.1996—

Also cleared against K120108: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260

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 14 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K253916 (Medartis AG, 2026) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K120108.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus.

The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

Indications for use as stated in the FDA summary.

Also cleared against K120108

1 other device cites the same predicate.

  • K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026

More from Medartis AG

42 FDA decisions under this applicant name. See the company

  • K260761APTUS Clavicle System 2.8Medartis AG · 2026
  • K260934TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026
  • K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
  • K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
  • K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG · 2024

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K181425 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181425: APTUS® Proximal 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/K181425

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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