510(k) · Cleared
ClearedAPTUS® 3.5 TriLock Straight Plates
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 2, 2023 as substantially equivalent to K193633 (Medartis AG, 2020) and 4 other predicates after a 58-day review. Its family tree reaches back 7 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 2, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K000684 (2000). 40 ancestors in all, the oldest K882831 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 5 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 4 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 3 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 2 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 1 generation backK193639 APTUS® Foot 2.8-3.5 SystemMedartis AG · 2020
- This deviceK230971 APTUS® 3.5 TriLock Straight PlatesMedartis AG · 2023
- Descendant · cites it directly · 1 of its ownK232251 APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire…Medartis AG · 2023
- Descendant · 2 generations on · 0 of its ownK260934 TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −6 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −5 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −4 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −3 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −2 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −1 | K193639 | APTUS® Foot 2.8-3.5 System | Medartis AG | 2020 | — |
| 0 (this device) | K230971 | APTUS® 3.5 TriLock Straight Plates | Medartis AG | 2023 | — |
| +1 | K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line… | Medartis AG | 2023 | — |
| +2 | K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | K193633 | APTUS® Ankle Trauma System 2.8/3.5Summary page 4…lth Technology 6 (Orthopedic Devices) Division of Health Technology 6 C (Restorative, Repair and Trauma Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K 193633, APTUS® Ankle Trauma System 2.8/3.5, Medartis AG Additional Predicate Devices K082807, Synthes (USA) 3.5 mm and 4.5 mm Locking… | 2020 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 4…air and Trauma Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K 193633, APTUS® Ankle Trauma System 2.8/3.5, Medartis AG Additional Predicate Devices K082807, Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications, Synthes (USA) KO011335, Synt… | 2008 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 5…s. The [FUS for the subject device and predicate device K193639 include language that includes use in the foot. The IFUS for the additional predicate devices K082807 and K011335 include language referring to fixation of the pelvis that is not relevant to the subject device. The IFUS for K082807 and K011335… | 2001 |
| * | K110908 | Aptus Foot 3.5 SystemSummary page 4…es (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications, Synthes (USA) KO011335, Synthes One-Third Tubular DCL Plate, Synthes (USA) K110908, APTUS® Foot 3.5 System, Medartis AG K193639, APTUS® Foot 2.8-3.5 System, Medartis AG K230971 Page 2 of 5 The AP… | 2011 |
| * | K193639 | APTUS® Foot 2.8-3.5 SystemSummary page 4…n Plate (LCP) System with Expanded Indications, Synthes (USA) KO011335, Synthes One-Third Tubular DCL Plate, Synthes (USA) K110908, APTUS® Foot 3.5 System, Medartis AG K193639, APTUS® Foot 2.8-3.5 System, Medartis AG K230971 Page 2 of 5 The APTUS 3.5 TriLock Straight Plates are intended… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | 2023 | 1 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 10 of the 40 ancestors have a recall of any class.
- Of its descendants, K232251 (Medartis AG, 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K193633.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 3.5 TriLock Straight Plates are intended for the fixation of fractures, osteotomies and non-unions of the scapula, olecranon, radius, ulna, foot, distal tibia and fibula.
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/K230971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230971: APTUS® 3.5 TriLock Straight Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230971
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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