510(k) · Cleared
Recalled · Class II · 2019Proximal Humerus Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miami Device Solutions · HRS Plate, Fixation, Bone
Cleared on Mar 20, 2015 as substantially equivalent to K041965 (Arthrex, Inc., 2004) and 2 other predicates after a 288-day review. Its family tree reaches back 7 generations to 1996. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 20, 2015
- Review
- 288 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K962616 (1996). 39 ancestors in all, the oldest K890939 (1989). 7 later devices descend from it, 3 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 backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 1 generation backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- This deviceK141493 Proximal Humerus Plating SystemMiami Device Solutions · 2015
- Descendant · cites it directly · 4 of its ownK161292 Distal Radius Plating SystemMiami Device Solutions, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK162635 Distal Radius Plating SystemMiami Device Solutions, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK162898 Olecranon Plating SystemMiami Device Solutions, LLC · 2017
- Descendant · cites it directly · 1 of its ownK161058 Cannulated ScrewMiami Device Solutions, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK182810 Distal Radius Plating SystemMiami Device Solutions, LLC · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161292Distal Radius Plating SystemMiami Device Solutions, LLC · 2016 · cites it directly4descendants
- K162635Distal Radius Plating SystemMiami Device Solutions, LLC · 2016 · 2 generations on2descendants
- K162898Olecranon Plating SystemMiami Device Solutions, LLC · 2017 · 2 generations on1descendant
- K161058Cannulated ScrewMiami Device Solutions, LLC · 2016 · cites it directly1descendant
- K182810Distal Radius Plating SystemMiami Device Solutions, LLC · 2018 · 2 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 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −1 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| 0 (this device) | K141493 | Proximal Humerus Plating System | Miami Device Solutions | 2015 | — |
| +1 | K161292 | Distal Radius Plating System | Miami Device Solutions, LLC | 2016 | — |
| +2 | K162635 | Distal Radius Plating System | Miami Device Solutions, LLC | 2016 | — |
| +2 | K162898 | Olecranon Plating System | Miami Device Solutions, LLC | 2017 | — |
| +1 | K161058 | Cannulated Screw | Miami Device Solutions, LLC | 2016 | — |
| +2 | K182810 | Distal Radius Plating System | Miami Device Solutions, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K041965 | Arthrex Humeral Fracture Plates and ScrewsSummary page 4…Class II per 21 CFR 888.3030 Device Product Code: HRS / HWC Predicate Devices: Arthrex Humeral Fracture Plates and Screws – K041965 Smith and Nephew Inc. Peri-Loc Locking Bone Plates and Locking Bone Screws for the… | 2004 |
| * | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySummary page 4…Smith and Nephew Inc. Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper -Extremity - K051735 Zimmer Universal Locking System, 3.5mm - K081759 Device Description: The Proxim… | 2005 |
| * | K081759 | NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…Summary page 4…and Locking Bone Screws for the Upper -Extremity - K051735 Zimmer Universal Locking System, 3.5mm - K081759 Device Description: The Proximal Humerus Plating System is an internal fixation plate system to be used for… | 2008 |
What descends from it? (7)
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 |
|---|---|---|---|---|
| Jan 15, 2019 | Class II | Z-0603-2020 | Process control | Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 39 ancestors have a recall of any class.
- Of its descendants, K161292 (Miami Device Solutions, LLC, 2016) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K041965.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 MDS Proximal Humerus Plating System is intended to provide internal fixation of fractures of the proximal humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141493: Proximal Humerus Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141493
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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