510(k) · Cleared
ClearedAPTUS® Ankle Trauma 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 Mar 26, 2020 as substantially equivalent to K013248 (Synthes (Usa), 2001) and 5 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1988. 11 later devices descend from it.
- Decided
- Mar 26, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K882831 (1988). 13 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK882831 Ace Cancellous Bone ScrewBuckman Co., Inc. · 1988
- 2 generations backK072832 Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- 1 generation backK092812 Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010
- This deviceK193633 APTUS® Ankle Trauma System 2.8/3.5Medartis AG · 2020
- Descendant · cites it directly · 5 of its ownK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023
- Descendant · cites it directly · 4 of its ownK240613 APTUS Elbow Dorsal Olecranon PlatesMedartis AG · 2024
- Descendant · 2 generations on · 3 of its ownK234062 APTUS Hand Scaphoid PlatesMedartis AG · 2024
- Descendant · 2 generations on · 2 of its ownK243610 APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
- Descendant · cites it directly · 2 of its ownK230971 APTUS® 3.5 TriLock Straight PlatesMedartis AG · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K223853Medartis APTUS® Ulna PlatesMedartis AG · 2023 · cites it directly5descendants
- K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG · 2024 · cites it directly4descendants
- K234062APTUS Hand Scaphoid PlatesMedartis AG · 2024 · 2 generations on3descendants
- K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025 · 2 generations on2descendants
- K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG · 2023 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882831 | Ace Cancellous Bone Screw | Buckman Co., Inc. | 1988 | — |
| −2 | K072832 | Anterolateral and Medial Locking Plating System | DePuy Orthopaedics, Inc. | 2007 | 2 |
| −1 | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates | Synthes (Usa) | 2010 | — |
| 0 (this device) | K193633 | APTUS® Ankle Trauma System 2.8/3.5 | Medartis AG | 2020 | — |
| +1 | K223853 | Medartis APTUS® Ulna Plates | Medartis AG | 2023 | — |
| +1 | K240613 | APTUS Elbow Dorsal Olecranon Plates | Medartis AG | 2024 | — |
| +2 | K234062 | APTUS Hand Scaphoid Plates | Medartis AG | 2024 | — |
| +2 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | 2025 | — |
| +1 | K230971 | APTUS® 3.5 TriLock Straight Plates | Medartis AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 4…on Division of Health Technology 6 C (Restorative, Repair and Trauma Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K013248, Synthes (USA) LCP Distal Tibia Plates, Synthes (USA) Additional Predicate Devices K092812, Synthes (USA) 2.7mm / 3.5mm LCP Ante… | 2001 |
| * | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSummary page 4…ir and Trauma Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K013248, Synthes (USA) LCP Distal Tibia Plates, Synthes (USA) Additional Predicate Devices K092812, Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates, Synthes (USA) K011335, Synthes One-third Tubular DCL Plate, S… | 2010 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 4…thes (USA) LCP Distal Tibia Plates, Synthes (USA) Additional Predicate Devices K092812, Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates, Synthes (USA) K011335, Synthes One-third Tubular DCL Plate, Synthes (USA) K083213, Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates, Synthes (USA) K00068… | 2001 |
| * | K083213 | Synthes 2.7 MM/3.5 MM LCP Distal Fibula PlatesSummary page 4…l Predicate Devices K092812, Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates, Synthes (USA) K011335, Synthes One-third Tubular DCL Plate, Synthes (USA) K083213, Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates, Synthes (USA) K000684, Small Fragment Dynamic Compression Locking (DCL) System,… | 2008 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 4…ral Distal Tibia Plates, Synthes (USA) K011335, Synthes One-third Tubular DCL Plate, Synthes (USA) K083213, Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates, Synthes (USA) K000684, Small Fragment Dynamic Compression Locking (DCL) System, Synthes (USA) K091479, APTUS® Foot System, Medartis AG… | 2000 |
| * | K091479 | Aptus Foot SystemSummary page 4…ate, Synthes (USA) K083213, Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates, Synthes (USA) K000684, Small Fragment Dynamic Compression Locking (DCL) System, Synthes (USA) K091479, APTUS® Foot System, Medartis AG 510(k) Summary… | 2009 |
| † | K103332 | Aptus Ulna Plates | 2011 |
| † | K192297 | APTUS Wrist Arthrodesis Plates | 2019 |
| † | K191848 | APTUS Wrist Spanning Plates 2.5 | 2019 |
What descends from it? (11)
See all 114 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 32 years and passes through 4 companies; a new generation was cleared every 9.9 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K223853 (Medartis AG, 2023) has gone furthest, with 5 descendants of its own.
- 19 other devices also cite its predicate K013248.
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® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193633: APTUS® Ankle Trauma System 2.8/3.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193633
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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