510(k) · Cleared
ClearedAPTUS (R) Wrist 2.5 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 Sep 8, 2017 as substantially equivalent to K142906 (Medartis AG, 2015) and 1 other predicate after a 52-day review. Its family tree reaches back 7 generations to 1996. 8 later devices descend from it.
- Decided
- Sep 8, 2017
- Review
- 52 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962616 (1996). 21 ancestors in all, the oldest K885250 (1989). 8 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 2 generations backK103332 Aptus Ulna PlatesMedartis AG · 2011
- 1 generation backK142906 APTUS Wrist 2.5 SystemMedartis AG · 2015
- This deviceK172170 APTUS (R) Wrist 2.5 SystemMedartis AG · 2017
- Descendant · cites it directly · 3 of its ownK232144 Sterile Products of the APTUS SystemMedartis AG · 2023
- Descendant · 2 generations on · 2 of its ownK243610 APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
- Descendant · cites it directly · 1 of its ownK260390 Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
- Descendant · 2 generations on · 0 of its ownK262537 Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
- Descendant · 3 generations on · 0 of its ownK260761 APTUS Clavicle System 2.8Medartis AG · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K232144Sterile Products of the APTUS SystemMedartis AG · 2023 · cites it directly3descendants
- K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025 · 2 generations on2descendants
- K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · cites it directly1descendant
- K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · 2 generations on0descendants
- K260761APTUS Clavicle System 2.8Medartis AG · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −4 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −2 | K103332 | Aptus Ulna Plates | Medartis AG | 2011 | — |
| −1 | K142906 | APTUS Wrist 2.5 System | Medartis AG | 2015 | — |
| 0 (this device) | K172170 | APTUS (R) Wrist 2.5 System | Medartis AG | 2017 | — |
| +1 | K232144 | Sterile Products of the APTUS System | Medartis AG | 2023 | — |
| +2 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | 2025 | — |
| +1 | K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +2 | K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +3 | K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026 | — |
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 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K142906 | APTUS Wrist 2.5 SystemSummary page 4…Classification Panel Orthopedic Products Panel Reviewing Branch Joint Fixation Devices Branch Two (JFDB2) PREDICATE DEVICE INFORMATION The primary predicate device is K142906. The reference predicate device is KO51567. INDICATIONS FOR USE APTUS® Wrist 2.5 System is intended for use in hand and forearm… | 2015 |
| * | K051567 | Aptus Titanium Osteosynthesis SystemSummary page 5…o accommodate appropriately sized bone screws (locking and non-locking) presently marketed as part of the APTUS System and previously cleared under K142906, K103332, and K051567. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of unalloye… | 2005 |
What descends from it? (8)
4 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 21 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K232144 (Medartis AG, 2023) has gone furthest, with 3 descendants of its own.
- 15 other devices also cite its predicate K142906.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies, and arthrodeses.
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/K172170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172170: APTUS (R) Wrist 2.5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172170
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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