510(k) · Cleared
ClearedAptus Foot 3.5 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 Jun 28, 2011 as substantially equivalent to K991407 (Synthes (Usa), 1999) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1998. 25 later devices descend from it.
- Decided
- Jun 28, 2011
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981372 (1998). 3 ancestors in all. 25 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 1 generation backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- This deviceK110908 Aptus Foot 3.5 SystemMedartis AG · 2011
- Descendant · cites it directly · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK193222 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020
- Descendant · 3 generations on · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- Descendant · 3 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
- Descendant · 2 generations on · 5 of its ownK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · cites it directly19descendants
- K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020 · 2 generations on11descendants
- K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · 3 generations on10descendants
- K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 3 generations on9descendants
- K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −1 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| 0 (this device) | K110908 | Aptus Foot 3.5 System | Medartis AG | 2011 | — |
| +1 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
| +2 | K193222 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2020 | — |
| +3 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
| +3 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | — |
| +2 | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Additive Orthopaedics | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 8 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K991407 | Synthes Locking Calcaneal PlatesSummary page 2…each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: Synthes (USA), Synthes Locking Calcaneal Plates, cleared under K99 1407, and Medantis AG, APTUS® Foot System, cleared under K091479. The subject device and the predicate devices have the same… | 1999 |
| * | K091479 | Aptus Foot SystemSummary page 2…ent to pre-amendment devices: Synthes (USA), Synthes Locking Calcaneal Plates, cleared under K99 1407, and Medantis AG, APTUS® Foot System, cleared under K091479. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The su… | 2009 |
What descends from it? (25)
See all 254 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 13 years and passes through 2 companies; a new generation was cleared every 12.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K162674 (Biopro, Inc., 2017) has gone furthest, with 19 descendants of its own.
- 15 other devices also cite its predicate K991407.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 3.5 System is indicated for fractures and osteotomies of the calcaneus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110908: Aptus Foot 3.5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110908
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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