510(k) · Cleared
Recalled · Class II · 2014Aptus Ulna Shortening 2.5
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 Jun 23, 2014 as substantially equivalent to K051567 (Medartis, Inc., 2005) and 2 other predicates after a 41-day review. Its family tree reaches back 6 generations to 1996. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 2014
- Review
- 41 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K962616 (1996). 22 ancestors in all, the oldest K885250 (1989). 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 4 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 3 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 1 generation backK103332 Aptus Ulna PlatesMedartis AG · 2011
- This deviceK141232 Aptus Ulna Shortening 2.5Medartis AG · 2014
- Descendant · cites it directly · 1 of its ownK260390 Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
- Descendant · cites it directly · 1 of its ownK211592 Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK262537 Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
- Descendant · 2 generations on · 0 of its ownK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026
- Descendant · cites it directly · 0 of its ownK201962 Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · cites it directly1descendant
- K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021 · cites it directly1descendant
- K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · 2 generations on0descendants
- K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026 · 2 generations on0descendants
- K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −5 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −4 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −3 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −1 | K103332 | Aptus Ulna Plates | Medartis AG | 2011 | — |
| 0 (this device) | K141232 | Aptus Ulna Shortening 2.5 | Medartis AG | 2014 | — |
| +1 | K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +1 | K211592 | Avanti Orthopaedics Ulnar Shortening System | Avanti Orthopaedics, Inc. | 2021 | — |
| +2 | K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +2 | K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026 | — |
| +1 | K201962 | Skeletal Dynamics Ulnar Shortening Plating System | Skeletal Dynamics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 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? (3)
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…. DEVICE DESCRIPTION APTUS Ulna Shortening 2.5 system consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K05 1567), both locking and non- locking. This submission includes additional lengths of non-locking screws. Plates have a low overall hei… | 2005 |
| * | K103332 | Aptus Ulna PlatesSummary page 2…for the ulna. DEVICE DESCRIPTION APTUS Ulna Shortening 2.5 system consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K05 1567), both locking and non- locking. This submission includes additional lengths of non-locking screws. Plates have a lo… | 2011 |
| * | K043263 | Trimed Osteotomy PlateSummary page 2…ium Fixation System, cleared under KO051567; Medartis AG, APTUS® Ulna Plates, cleared under K103332; and TriMed Inc., TriMed Ulnar Osteotomy Plate, cleared under K043263. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The su… | 2005 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2014 | Class II | Z-0150-2015 | Process design | A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K260390 (GM Dos Reis Industria e Comercio Ltda., 2026) has gone furthest, with 1 descendant 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. 2014, 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® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141232: Aptus Ulna Shortening 2.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141232
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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