510(k) · Cleared
ClearedDistal Radius Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miami Device Solutions, LLC · HRS Plate, Fixation, Bone
Cleared on Aug 15, 2016 as substantially equivalent to K012114 (Synthes (Usa), 2001) and 2 other predicates after a 98-day review. Its family tree reaches back 9 generations to 1996. 4 later devices descend from it.
- Decided
- Aug 15, 2016
- Review
- 98 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K962616 (1996). 43 ancestors in all, the oldest K890939 (1989). 4 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK060041 Trimed Bone PlatesTriMed, Inc. · 2006 · Recalled
- 1 generation backK141430 Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG · 2014
- This deviceK161292 Distal Radius Plating SystemMiami Device Solutions, LLC · 2016
- Descendant · cites it directly · 2 of its ownK162635 Distal Radius Plating SystemMiami Device Solutions, LLC · 2016
- Descendant · cites it directly · 1 of its ownK162898 Olecranon Plating SystemMiami Device Solutions, LLC · 2017
- Descendant · cites it directly · 0 of its ownK182810 Distal Radius Plating SystemMiami Device Solutions, LLC · 2018
- Descendant · cites it directly · 0 of its ownK172786 MDS Plating SystemMiami Device Solutions, LLC · 2017
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK060041 Trimed Bone PlatesTriMed, Inc. · 2006 · Recalled
- 1 generation backK141430 Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG · 2014
- This deviceK161292 Distal Radius Plating SystemMiami Device Solutions, LLC · 2016
Most influential descendants
Showing 4 of 4 · See all- K162635Distal Radius Plating SystemMiami Device Solutions, LLC · 2016 · cites it directly2descendants
- K162898Olecranon Plating SystemMiami Device Solutions, LLC · 2017 · cites it directly1descendant
- K182810Distal Radius Plating SystemMiami Device Solutions, LLC · 2018 · cites it directly0descendants
- K172786MDS Plating SystemMiami Device Solutions, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −2 | K060041 | Trimed Bone Plates | TriMed, Inc. | 2006 | 3 |
| −1 | K141430 | Variax Distal Radius Plating System | Stryker Leibinger GmbH & Co KG | 2014 | — |
| 0 (this device) | K161292 | Distal Radius Plating System | Miami Device Solutions, LLC | 2016 | — |
| +1 | K162635 | Distal Radius Plating System | Miami Device Solutions, LLC | 2016 | — |
| +1 | K162898 | Olecranon Plating System | Miami Device Solutions, LLC | 2017 | — |
| +1 | K182810 | Distal Radius Plating System | Miami Device Solutions, LLC | 2018 | — |
| +1 | K172786 | MDS Plating System | Miami Device Solutions, LLC | 2017 | — |
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 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K012114 | Synthes Locking Distal Radius Plating SystemSummary page 4…c Regulation Number: 21 CFR section 888.3030; and 888.3040 Predicate Devices: Synthes Locking Distal Radius Plate System – K012114 Variax Distal Radius Plating System – K141430 P… | 2001 |
| * | K141430 | Variax Distal Radius Plating SystemSummary page 4…dicate Devices: Synthes Locking Distal Radius Plate System – K012114 Variax Distal Radius Plating System – K141430 Proximal Humerus Plating System – K141493 Reference Devices: Para… | 2014 |
| * | K141493 | Proximal Humerus Plating SystemSummary page 4…K012114 Variax Distal Radius Plating System – K141430 Proximal Humerus Plating System – K141493 Reference Devices: Paragon 28, Inc.; The Monster Screw System: Instrument… | 2015 |
| † | K151418 | Monster Screw System | 2015 |
What descends from it? (4)
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 20 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 13 of the 43 ancestors have a recall of any class.
- Of its descendants, K162635 (Miami Device Solutions, LLC, 2016) has gone furthest, with 2 descendants of its own.
- 15 other devices also cite its predicate K012114.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Distal Radius Plating System is intended for internal fixation of fractures of the distal radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161292: Distal Radius 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/K161292
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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