510(k) · Cleared
ClearedAPTUS Clavicle System 2.8
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 5, 2026 as substantially equivalent to K192984 (Medartis AG, 2020) and 3 other predicates after an 88-day review. Its family tree reaches back 13 generations to 1979.
- Decided
- Jun 5, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K792022 (1979). 173 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations between
- 3 generations backK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023
- 2 generations backK234062 APTUS Hand Scaphoid PlatesMedartis AG · 2024
- 1 generation backK243610 APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
- This deviceK260761 APTUS Clavicle System 2.8Medartis AG · 2026
Show all 13 generations
- Root · 13 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 12 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 11 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 10 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 9 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 8 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 7 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 6 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 5 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 4 generations backK192984 APTUS Clavicle SystemMedartis AG · 2020
- 3 generations backK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023
- 2 generations backK234062 APTUS Hand Scaphoid PlatesMedartis AG · 2024
- 1 generation backK243610 APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
- This deviceK260761 APTUS Clavicle System 2.8Medartis AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −12 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −11 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −10 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −9 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −8 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −7 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −6 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −5 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −4 | K192984 | APTUS Clavicle System | Medartis AG | 2020 | — |
| −3 | K223853 | Medartis APTUS® Ulna Plates | Medartis AG | 2023 | — |
| −2 | K234062 | APTUS Hand Scaphoid Plates | Medartis AG | 2024 | — |
| −1 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | 2025 | — |
| 0 (this device) | K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 14 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 10 | 0 |
| 2001 | 14 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K192984 | APTUS Clavicle SystemSummary page 5…888.3030 Product Code(s) HRS | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192984 APTUS® Clavicle System HRS K111540 SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM HRS K243610 APTUS Hand System; APTUS Elbow Dorsal Olec… | 2020 |
| * | K111540 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 5…gally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192984 APTUS® Clavicle System HRS K111540 SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM HRS K243610 APTUS Hand System; APTUS Elbow Dorsal Olecranon HRS K061753 Synthes (USA) Cla… | 2011 |
| * | K243610 | APTUS Hand System; APTUS Elbow Dorsal OlecranonSummary page 5…Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192984 APTUS® Clavicle System HRS K111540 SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM HRS K243610 APTUS Hand System; APTUS Elbow Dorsal Olecranon HRS K061753 Synthes (USA) Clavicle Hook Plate HRS Device Description Summary 21 C… | 2025 |
| * | K061753 | Synthes (Usa) Clavicle Hook PlatesSummary page 5…ed first) Product Code K192984 APTUS® Clavicle System HRS K111540 SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM HRS K243610 APTUS Hand System; APTUS Elbow Dorsal Olecranon HRS K061753 Synthes (USA) Clavicle Hook Plate HRS Device Description Summary 21 CFR 807.92(a)(4) The purpose of this submission is to obtain… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 47 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 26 of the 173 ancestors have a recall of any class.
- 1 other device also cites its predicate K192984.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Implants from the APTUS Clavicle System are indicated for the treatment of fractures and osteotomies of the clavicle, and for dislocations of the acromioclavicular joint.
Clavicle plates
- fractures, osteotomies, malunions and non-unions of the clavicle
Clavicle Hook Plates
- fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
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/K260761 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260761: APTUS Clavicle System 2.8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260761
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026