510(k) · Cleared
ClearedAPTUS Clavicle 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 Jan 24, 2020 as substantially equivalent to K111540 (Synthes (Usa), 2011) and 3 other predicates after a 91-day review. Its family tree reaches back 9 generations to 1979. 6 later devices descend from it.
- Decided
- Jan 24, 2020
- Review
- 91 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K792022 (1979). 56 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations between
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 1 generation backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- This deviceK192984 APTUS Clavicle SystemMedartis AG · 2020
- Descendant · cites it directly · 5 of its ownK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023
- Descendant · 2 generations on · 3 of its ownK234062 APTUS Hand Scaphoid PlatesMedartis AG · 2024
- Descendant · 3 generations on · 2 of its ownK243610 APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
- Descendant · cites it directly · 0 of its ownK260761 APTUS Clavicle System 2.8Medartis AG · 2026
- Descendant · 4 generations on · 0 of its ownK253916 APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
Show all 9 generations
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 7 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 6 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 5 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 4 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 1 generation backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- This deviceK192984 APTUS Clavicle SystemMedartis AG · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K223853Medartis APTUS® Ulna PlatesMedartis AG · 2023 · cites it directly5descendants
- K234062APTUS Hand Scaphoid PlatesMedartis AG · 2024 · 2 generations on3descendants
- K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025 · 3 generations on2descendants
- K260761APTUS Clavicle System 2.8Medartis AG · 2026 · cites it directly0descendants
- K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −8 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −7 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −6 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −5 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −2 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −1 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| 0 (this device) | K192984 | APTUS Clavicle System | Medartis AG | 2020 | — |
| +1 | K223853 | Medartis APTUS® Ulna Plates | Medartis AG | 2023 | — |
| +2 | K234062 | APTUS Hand Scaphoid Plates | Medartis AG | 2024 | — |
| +3 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | 2025 | — |
| +1 | K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026 | — |
| +4 | 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 |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K111540 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 4…on Division of Health Technology 6 C (Restorative, Repair and Trauma Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K111540, Synthes 3.5 mm LCP Clavicle Plate System, Synthes (USA) Other Predicate Devices K073186, Synthes 3.5 mm LCP Clavicle Plate Syst… | 2011 |
| * | K073186 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 4…pair and Trauma Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K111540, Synthes 3.5 mm LCP Clavicle Plate System, Synthes (USA) Other Predicate Devices K073186, Synthes 3.5 mm LCP Clavicle Plate System, Synthes (USA) K101536, 2.7/3.5 mm VA-LCP Anterior Clavicle Plate System, Synthes (USA)… | 2007 |
| * | K101536 | 2.7/3.5MM VA-LCP Anteriro Clavicle Plate SystemSummary page 4…edicate Device K111540, Synthes 3.5 mm LCP Clavicle Plate System, Synthes (USA) Other Predicate Devices K073186, Synthes 3.5 mm LCP Clavicle Plate System, Synthes (USA) K101536, 2.7/3.5 mm VA-LCP Anterior Clavicle Plate System, Synthes (USA) K112111, Acu-Sinch Repair System, Acumed LLC 510… | 2010 |
| * | K112111 | Acu-Sinch Repair System and Acumed Suture AnchorSummary page 4…(USA) Other Predicate Devices K073186, Synthes 3.5 mm LCP Clavicle Plate System, Synthes (USA) K101536, 2.7/3.5 mm VA-LCP Anterior Clavicle Plate System, Synthes (USA) K112111, Acu-Sinch Repair System, Acumed LLC 510(k) Summary… | 2011 |
| † | K110176 | Axsos Locked Plating 4.0MM Locking Inserts | 2011 |
| † | K191848 | APTUS Wrist Spanning Plates 2.5 | 2019 |
| † | K181425 | APTUS® Proximal Humerus System | 2018 |
What descends from it? (6)
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 41 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 56 ancestors have a recall of any class.
- Of its descendants, K223853 (Medartis AG, 2023) has gone furthest, with 5 descendants of its own.
- 9 other devices also cite its predicate K111540.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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® Clavicle System is indicated for treatment of fractures, osteotomies, malunions and non-unions of the clavicle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192984 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192984: APTUS Clavicle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192984
Report an extraction error
Are you the manufacturer?
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