510(k) · Cleared
ClearedAPTUS Elbow Dorsal Olecranon 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 Jun 20, 2024 as substantially equivalent to K120070 (Synthes USA, 2012) and 2 other predicates after a 107-day review. Its family tree reaches back 11 generations to 1996. 4 later devices descend from it.
- Decided
- Jun 20, 2024
- Review
- 107 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K962616 (1996). 97 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- This deviceK240613 APTUS Elbow Dorsal Olecranon PlatesMedartis AG · 2024
- Descendant · cites it directly · 2 of its ownK243610 APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
- Descendant · 2 generations on · 0 of its ownK260761 APTUS Clavicle System 2.8Medartis AG · 2026
- Descendant · cites it directly · 0 of its ownK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK253916 APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- This deviceK240613 APTUS Elbow Dorsal Olecranon PlatesMedartis AG · 2024
Most influential descendants
Showing 4 of 4 · See all- K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025 · cites it directly2descendants
- K260761APTUS Clavicle System 2.8Medartis AG · 2026 · 2 generations on0descendants
- K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026 · cites it directly0descendants
- K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −1 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| 0 (this device) | K240613 | APTUS Elbow Dorsal Olecranon Plates | Medartis AG | 2024 | — |
| +1 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | 2025 | — |
| +2 | K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026 | — |
| +1 | K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026 | — |
| +2 | 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 |
|---|---|---|
| 1979 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2020 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K120070 | Synthes Variable Angle LCP Elbow SystemSummary page 4…ct Code(s) HRS (Primary), HWC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K120070 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM HRS K193633 APTUS Ankle Trauma System 2.8/3.5 HRS K193639 APTUS Foot System HRS Device De… | 2012 |
| * | K193633 | APTUS® Ankle Trauma System 2.8/3.5Summary page 4…edicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K120070 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM HRS K193633 APTUS Ankle Trauma System 2.8/3.5 HRS K193639 APTUS Foot System HRS Device Description Summary 21 CFR 807.92(a)(4) The purpose o… | 2020 |
| * | K193639 | APTUS® Foot 2.8-3.5 SystemSummary page 4…# Predicate Trade Name (Primary Predicate is listed first) Product Code K120070 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM HRS K193633 APTUS Ankle Trauma System 2.8/3.5 HRS K193639 APTUS Foot System HRS Device Description Summary 21 CFR 807.92(a)(4) The purpose of this submission is to obtain marketing clear… | 2020 |
What descends from it? (4)
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 28 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 21 of the 97 ancestors have a recall of any class.
- Of its descendants, K243610 (Medartis AG, 2025) has gone furthest, with 2 descendants of its own.
- 14 other devices also cite its predicate K120070.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular
for the ulna.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240613 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240613: APTUS Elbow Dorsal Olecranon Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240613
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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