510(k) · Cleared
ClearedSterile Products of the APTUS 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 Aug 18, 2023 as substantially equivalent to K051567 (Medartis, Inc., 2005) and 8 other predicates after a 30-day review. Its family tree reaches back 8 generations to 1996. 3 later devices descend from it.
- Decided
- Aug 18, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 8 generations to K962616 (1996). 33 ancestors in all, the oldest K885250 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 3 generations backK103332 Aptus Ulna PlatesMedartis AG · 2011
- 2 generations backK142906 APTUS Wrist 2.5 SystemMedartis AG · 2015
- 1 generation backK172170 APTUS (R) Wrist 2.5 SystemMedartis AG · 2017
- This deviceK232144 Sterile Products of the APTUS SystemMedartis AG · 2023
- Descendant · cites it directly · 2 of its ownK243610 APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
- Descendant · 2 generations on · 0 of its ownK260761 APTUS Clavicle System 2.8Medartis AG · 2026
- Descendant · 2 generations on · 0 of its ownK253916 APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −3 | K103332 | Aptus Ulna Plates | Medartis AG | 2011 | — |
| −2 | K142906 | APTUS Wrist 2.5 System | Medartis AG | 2015 | — |
| −1 | K172170 | APTUS (R) Wrist 2.5 System | Medartis AG | 2017 | — |
| 0 (this device) | K232144 | Sterile Products of the APTUS System | Medartis AG | 2023 | — |
| +1 | K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG | 2025 | — |
| +2 | K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026 | — |
| +2 | K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (9)
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 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K051567 APTUS@ Titanium Fixation System I HRS IK090983 I APTUS® 2.0… | 2005 |
| * | K090983 | Aptus 2.0/2.3 Four Corner Fusion PlateSummary page 5…rimary Predicate is listed first) Product Code I K051567 APTUS@ Titanium Fixation System I HRS IK090983 I APTUS® 2.0/2.3 Four Corner Fusion Plates I HRS IK092038 APTUS®… | 2009 |
| * | K092038 | Aptus K-Wire SystemSummary page 5…Fixation System I HRS IK090983 I APTUS® 2.0/2.3 Four Corner Fusion Plates I HRS IK092038 APTUS® K-Wire System I HTY I K102537 I APTUS@ 1.… | 2009 |
| * | K102537 | Aptus 1.5 TrilockSummary page 5…r Corner Fusion Plates I HRS IK092038 APTUS® K-Wire System I HTY I K102537 I APTUS@ 1.5 TriLock I HRS I K103332 APTUS@ U… | 2010 |
| * | K103332 | Aptus Ulna PlatesSummary page 5…stem I HTY I K102537 I APTUS@ 1.5 TriLock I HRS I K103332 APTUS@ Ulna System I HRS K142906… | 2011 |
| * | K142906 | APTUS Wrist 2.5 SystemSummary page 6…I HRS I K103332 APTUS@ Ulna System I HRS K142906 APTUS® Wrist 2.5 System HRS K17217… | 2015 |
| * | K172170 | APTUS (R) Wrist 2.5 SystemSummary page 6…I HRS K142906 APTUS® Wrist 2.5 System HRS K172170 APTUS® Wrist 2.5 System HRS K19229… | 2017 |
| * | K192297 | APTUS Wrist Arthrodesis PlatesSummary page 6…HRS K172170 APTUS® Wrist 2.5 System HRS K192297 APTUS® Wrist Arthrodesis System HRS K19355… | 2019 |
| * | K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemSummary page 6…HRS K192297 APTUS® Wrist Arthrodesis System HRS K193554 I APTUS® Forearm Shaft Plates HRS K19184… | 2020 |
| † | K191848 | APTUS Wrist Spanning Plates 2.5 | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243610 | APTUS Hand System; APTUS Elbow Dorsal Olecranon | 2025 | 2 |
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 27 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 6 of the 33 ancestors have a recall of any class.
- Of its descendants, K243610 (Medartis AG, 2025) has gone furthest, with 2 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. 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?
APTUS® Titanium Fixation System The APTUS® Titanium Fixation System is indicated 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 fractures, comminuted fractures, dislocation fractures, avulsion…
Read the full statement (462 words)
APTUS® Titanium Fixation System
The APTUS® Titanium Fixation System is indicated 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 fractures, comminuted fractures, dislocation fractures, avulsion fractures
• DIP and PIP arthrodeses
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.
APTUS® 2.0/2.3 Four Corner Fusion Plate
The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.
APTUS® K-Wire System
The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.
APTUS® 1.5 TriLock
The APTUS® 1.5 TriLock is indicated 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 fractures, comminuted fractures, dislocation fractures, avulsion fractures
• DIP and PIP arthrodeses
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.
APTUS® Ulna Plates
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
APTUS® Wrist 2.5 System
APTUS® Wrist 2.5 System is indicated for use in hand and forearm fractures, osteotomies and arthrodeses.
APTUS® Wrist Arthrodesis Plates
APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.
APTUS® Forearm Shaft Plates
APTUS® Forearm Shaft Plates are indicated for management of fractures and osteotomies of the radius and ulna shaft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232144: Sterile Products of the APTUS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232144
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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