510(k) · Cleared
ClearedMedartis APTUS® 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 Mar 30, 2023 as substantially equivalent to K103332 (Medartis AG, 2011) and 5 other predicates after a 97-day review. Its family tree reaches back 10 generations to 1979. 5 later devices descend from it.
- Decided
- Mar 30, 2023
- Review
- 97 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K792022 (1979). 98 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations between
- 3 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 2 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 1 generation backK192984 APTUS Clavicle SystemMedartis AG · 2020
- This deviceK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023
- Descendant · cites it directly · 3 of its ownK234062 APTUS Hand Scaphoid PlatesMedartis AG · 2024
- Descendant · 2 generations on · 2 of its ownK243610 APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
- Descendant · 3 generations on · 0 of its ownK260761 APTUS Clavicle System 2.8Medartis AG · 2026
- Descendant · 3 generations on · 0 of its ownK253916 APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
- Descendant · cites it directly · 0 of its ownK232105 APTUS Foot System 2.8-3.5Medartis AG · 2024
Show all 10 generations
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 8 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 7 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 6 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 5 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 4 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 3 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 2 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 1 generation backK192984 APTUS Clavicle SystemMedartis AG · 2020
- This deviceK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023
Most influential descendants
Showing 5 of 5 · See all- K234062APTUS Hand Scaphoid PlatesMedartis AG · 2024 · cites it directly3descendants
- K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025 · 2 generations on2descendants
- K260761APTUS Clavicle System 2.8Medartis AG · 2026 · 3 generations on0descendants
- K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026 · 3 generations on0descendants
- K232105APTUS Foot System 2.8-3.5Medartis AG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −9 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −8 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −7 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −6 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −5 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −4 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −3 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −2 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −1 | K192984 | APTUS Clavicle System | Medartis AG | 2020 | — |
| 0 (this device) | K223853 | Medartis APTUS® Ulna Plates | Medartis AG | 2023 | — |
| +1 | K234062 | APTUS Hand Scaphoid Plates | Medartis AG | 2024 | — |
| +2 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | 2025 | — |
| +3 | K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026 | — |
| +3 | K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | 2026 | — |
| +1 | K232105 | APTUS Foot System 2.8-3.5 | Medartis AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K103332 | Aptus Ulna PlatesSummary page 4…HRS Classification Panel Orthopedic PREDICATE DEVICE INFORMATION Primary Predicate Device K103332, APTUS Ulna Plates, Medartis AG; Additional Predicate Devices K193633, APTUS® Ankle Trauma System 2.8/3.… | 2011 |
| * | K193633 | APTUS® Ankle Trauma System 2.8/3.5Summary page 4…DICATE DEVICE INFORMATION Primary Predicate Device K103332, APTUS Ulna Plates, Medartis AG; Additional Predicate Devices K193633, APTUS® Ankle Trauma System 2.8/3.5, Medartis AG; K193554, APTUS® Forearm, Medartis AG; K192984, APTUS® C… | 2020 |
| * | K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemSummary page 4…K103332, APTUS Ulna Plates, Medartis AG; Additional Predicate Devices K193633, APTUS® Ankle Trauma System 2.8/3.5, Medartis AG; K193554, APTUS® Forearm, Medartis AG; K192984, APTUS® Clavicle System, Meadrtis AG; K192297, APTUS® Wrist Arthrod… | 2020 |
| * | K192984 | APTUS Clavicle SystemSummary page 4…Additional Predicate Devices K193633, APTUS® Ankle Trauma System 2.8/3.5, Medartis AG; K193554, APTUS® Forearm, Medartis AG; K192984, APTUS® Clavicle System, Meadrtis AG; K192297, APTUS® Wrist Arthrodesis Plates, Medartis AG; K142906, APT… | 2020 |
| * | K192297 | APTUS Wrist Arthrodesis PlatesSummary page 4…APTUS® Ankle Trauma System 2.8/3.5, Medartis AG; K193554, APTUS® Forearm, Medartis AG; K192984, APTUS® Clavicle System, Meadrtis AG; K192297, APTUS® Wrist Arthrodesis Plates, Medartis AG; K142906, APTUS® Wrist 2.5 System, Medartis AG… | 2019 |
| * | K142906 | APTUS Wrist 2.5 SystemSummary page 4…54, APTUS® Forearm, Medartis AG; K192984, APTUS® Clavicle System, Meadrtis AG; K192297, APTUS® Wrist Arthrodesis Plates, Medartis AG; K142906, APTUS® Wrist 2.5 System, Medartis AG Page 1 of 3 Tra… | 2015 |
What descends from it? (5)
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 44 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 14 of the 98 ancestors have a recall of any class.
- Of its descendants, K234062 (Medartis AG, 2024) has gone furthest, with 3 descendants of its own.
- 11 other devices also cite its predicate K103332.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 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/K223853 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223853: Medartis APTUS® Ulna Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223853
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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