510(k) · Cleared
ClearedAptus 1.5 Trilock
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 Dec 10, 2010 as substantially equivalent to K051567 (Medartis, Inc., 2005) after a 98-day review. Its family tree reaches back 5 generations to 1996. 19 later devices descend from it.
- Decided
- Dec 10, 2010
- Review
- 98 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962616 (1996). 15 ancestors in all, the oldest K885250 (1989). 19 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 4 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 3 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 2 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 1 generation backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- This deviceK102537 Aptus 1.5 TrilockMedartis AG · 2010
- Descendant · cites it directly · 7 of its ownK132769 Acumed Hand Plating SystemAcumed, LLC · 2014
- Descendant · 2 generations on · 6 of its ownK141383 Acumed Hand Fracture SystemAcumed, LLC · 2014
- Descendant · cites it directly · 4 of its ownK140617 Pinit Small Bone Fusion SystemArthrosurface, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK234062 APTUS Hand Scaphoid PlatesMedartis AG · 2024
- Descendant · cites it directly · 3 of its ownK232144 Sterile Products of the APTUS SystemMedartis AG · 2023
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K132769Acumed Hand Plating SystemAcumed, LLC · 2014 · cites it directly7descendants
- K141383Acumed Hand Fracture SystemAcumed, LLC · 2014 · 2 generations on6descendants
- K140617Pinit Small Bone Fusion SystemArthrosurface, Inc. · 2014 · cites it directly4descendants
- K234062APTUS Hand Scaphoid PlatesMedartis AG · 2024 · cites it directly3descendants
- K232144Sterile Products of the APTUS SystemMedartis AG · 2023 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −4 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −3 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −2 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −1 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| 0 (this device) | K102537 | Aptus 1.5 Trilock | Medartis AG | 2010 | — |
| +1 | K132769 | Acumed Hand Plating System | Acumed, LLC | 2014 | — |
| +2 | K141383 | Acumed Hand Fracture System | Acumed, LLC | 2014 | — |
| +1 | K140617 | Pinit Small Bone Fusion System | Arthrosurface, Inc. | 2014 | — |
| +1 | K234062 | APTUS Hand Scaphoid Plates | Medartis AG | 2024 | — |
| +1 | K232144 | Sterile Products of the APTUS System | Medartis AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K051567 | Aptus Titanium Osteosynthesis SystemSummary page 2…lates may also be used with existing standard 1.2 mmn (thread diameter) and 1.5 mmn (thread diameter) contical bone screws cleared under APTUS® Titanium Fixation System, K05 1567. The only modifications being made in this submission are the addition of eight (8) plates, all 0.8 mmn in thickness, having vari… | 2005 |
What descends from it? (19)
See all 196 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 14 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K132769 (Acumed, LLC, 2014) has gone furthest, with 7 descendants of its own.
- 21 other devices also cite its predicate K051567.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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® 1.5 TniLock is intended for use in hand and forearm fractures, osteotomies and arthrodeses. APTUS® Hand group: * Management of the fractures of the distal, middle and proximal phalanges and metacarpals * Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures * DIP and PIP arthrodoses APTUS®…
Read the full statement (134 words)
The APTUS® 1.5 TniLock is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
APTUS® Hand group:
* Management of the fractures of the distal, middle and proximal phalanges and metacarpals
* Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures
* DIP and PIP arthrodoses
APTUS® Radius 2.5 group:
* Management via radio volar approach of extra-articular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
* Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102537: Aptus 1.5 Trilock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102537
Report an extraction error
Are you the manufacturer?
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