510(k) · Cleared
ClearedAPTUS Foot System 2.8-3.5
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 Apr 19, 2024 as substantially equivalent to K193639 (Medartis AG, 2020) and 7 other predicates after a 280-day review. Its family tree reaches back 11 generations to 1979.
- Decided
- Apr 19, 2024
- Review
- 280 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 11 generations to K792022 (1979). 110 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK232105 APTUS Foot System 2.8-3.5Medartis AG · 2024
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 deviceK232105 APTUS Foot System 2.8-3.5Medartis AG · 2024
View 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) | 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 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 8 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (8)
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 |
|---|---|---|---|
| * | K193639 | APTUS® Foot 2.8-3.5 SystemSummary page 4…mary): 21 CFR 888.3040 HRS (Primary); HWC; PLF Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K193639 APTUS® Foot 2.8 — 3.5 System HRS K223853 Medartis APTUS® Ulna Plates HRS K091479 APTUS FOOT SYSTEM HRS K052614 LOW PROFILE PLATE… | 2020 |
| * | K223853 | Medartis APTUS® Ulna PlatesSummary page 4…C; PLF Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K193639 APTUS® Foot 2.8 — 3.5 System HRS K223853 Medartis APTUS® Ulna Plates HRS K091479 APTUS FOOT SYSTEM HRS K052614 LOW PROFILE PLATE AND SCREW SYSTEM HRS K150520 DARCO Lockin… | 2023 |
| * | K091479 | Aptus Foot SystemSummary page 4…a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K193639 APTUS® Foot 2.8 — 3.5 System HRS K223853 Medartis APTUS® Ulna Plates HRS K091479 APTUS FOOT SYSTEM HRS K052614 LOW PROFILE PLATE AND SCREW SYSTEM HRS K150520 DARCO Locking Bone Plate System HRS K103332 APTUS UL… | 2009 |
| * | K052614 | Low Profile Plate and Screw SystemSummary page 4…rade Name (Primary Predicate is listed first) Product Code K193639 APTUS® Foot 2.8 — 3.5 System HRS K223853 Medartis APTUS® Ulna Plates HRS K091479 APTUS FOOT SYSTEM HRS K052614 LOW PROFILE PLATE AND SCREW SYSTEM HRS K150520 DARCO Locking Bone Plate System HRS K103332 APTUS ULNA PLATES HRS K193633 APTUS® A… | 2005 |
| * | K150520 | DARCO Locking Bone Plate SystemSummary page 4…roduct Code K193639 APTUS® Foot 2.8 — 3.5 System HRS K223853 Medartis APTUS® Ulna Plates HRS K091479 APTUS FOOT SYSTEM HRS K052614 LOW PROFILE PLATE AND SCREW SYSTEM HRS K150520 DARCO Locking Bone Plate System HRS K103332 APTUS ULNA PLATES HRS K193633 APTUS® Ankle Trauma System 2.8/3.5 HRS K110908 APTUS FO… | 2015 |
| * | K103332 | Aptus Ulna PlatesSummary page 4…stem HRS K223853 Medartis APTUS® Ulna Plates HRS K091479 APTUS FOOT SYSTEM HRS K052614 LOW PROFILE PLATE AND SCREW SYSTEM HRS K150520 DARCO Locking Bone Plate System HRS K103332 APTUS ULNA PLATES HRS K193633 APTUS® Ankle Trauma System 2.8/3.5 HRS K110908 APTUS FOOT 3.5 SYSTEM HRS Device Description Summary… | 2011 |
| * | K193633 | APTUS® Ankle Trauma System 2.8/3.5Summary page 4…S® Ulna Plates HRS K091479 APTUS FOOT SYSTEM HRS K052614 LOW PROFILE PLATE AND SCREW SYSTEM HRS K150520 DARCO Locking Bone Plate System HRS K103332 APTUS ULNA PLATES HRS K193633 APTUS® Ankle Trauma System 2.8/3.5 HRS K110908 APTUS FOOT 3.5 SYSTEM HRS Device Description Summary 21 CFR 807.92(a)(4) The purp… | 2020 |
| * | K110908 | Aptus Foot 3.5 SystemSummary page 4…S K052614 LOW PROFILE PLATE AND SCREW SYSTEM HRS K150520 DARCO Locking Bone Plate System HRS K103332 APTUS ULNA PLATES HRS K193633 APTUS® Ankle Trauma System 2.8/3.5 HRS K110908 APTUS FOOT 3.5 SYSTEM HRS Device Description Summary 21 CFR 807.92(a)(4) The purpose of this submission is to obtain marketing c… | 2011 |
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 45 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 16 of the 110 ancestors have a recall of any class.
- 2 other devices also cite its predicate K193639.
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 Foot System 2.8-3.5 is indicated for use in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
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/K232105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232105: APTUS Foot System 2.8-3.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232105
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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