510(k) · Cleared
ClearedAPTUS Hand Scaphoid 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 21, 2024 as substantially equivalent to K102537 (Medartis AG, 2010) and 1 other predicate after a 90-day review. Its family tree reaches back 11 generations to 1979. 3 later devices descend from it.
- Decided
- Mar 21, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K792022 (1979). 100 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations between
- 3 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 2 generations backK192984 APTUS Clavicle SystemMedartis AG · 2020
- 1 generation backK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023
- This deviceK234062 APTUS Hand Scaphoid 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 · 2 generations on · 0 of its ownK253916 APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
Show all 11 generations
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 9 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 8 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 7 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 6 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 5 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 4 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 3 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 2 generations backK192984 APTUS Clavicle SystemMedartis AG · 2020
- 1 generation backK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023
- This deviceK234062 APTUS Hand Scaphoid PlatesMedartis AG · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −10 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −9 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −8 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −7 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −6 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −5 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −4 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −3 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −2 | K192984 | APTUS Clavicle System | Medartis AG | 2020 | — |
| −1 | K223853 | Medartis APTUS® Ulna Plates | Medartis AG | 2023 | — |
| 0 (this device) | K234062 | APTUS Hand Scaphoid 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 | — |
| +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 |
|---|---|---|
| 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 | 3 | 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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K102537 | Aptus 1.5 TrilockSummary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K102537 1.2/1.5 TriLock Plate 3/5 Hole T, tO.8 HRS K223853… | 2010 |
| * | K223853 | Medartis APTUS® Ulna PlatesSummary page 4…Product Code K102537 1.2/1.5 TriLock Plate 3/5 Hole T, tO.8 HRS K223853 2.5 TriLock Distal Ulna Plates HRS IDevice Desc… | 2023 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | 2025 | 2 |
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 45 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 14 of the 100 ancestors have a recall of any class.
- Of its descendants, K243610 (Medartis AG, 2025) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K102537.
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?
APTUS Hand Scaphoid Plates are indicated for fractures and non-unions of the scaphoid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234062 · printed Nov 5, 2026
Cite this page
510(k) Report. “K234062: APTUS Hand Scaphoid Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K234062
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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