510(k) · Cleared
ClearedGeminus Volar Distal Radius Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 13, 2025 as substantially equivalent to K182492 (Skeletal Dynamics, LLC, 2018) after a 58-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Nov 13, 2025
- Review
- 58 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963798 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK963798 Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP)…Synthes (Usa) · 1996
- 2 generations backK111620 Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3…Skeletal Dynamics, LLC · 2011
- 1 generation backK182492 Geminus Volar Distal Radius Plate SystemSkeletal Dynamics, LLC · 2018
- This deviceK252949 Geminus Volar Distal Radius Plating SystemSkeletal Dynamics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963798 | Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System | Synthes (Usa) | 1996 | — |
| −2 | K111620 | Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole… | Skeletal Dynamics, LLC | 2011 | — |
| −1 | K182492 | Geminus Volar Distal Radius Plate System | Skeletal Dynamics, LLC | 2018 | — |
| 0 (this device) | K252949 | Geminus Volar Distal Radius Plating System | Skeletal Dynamics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (1)
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 |
|---|---|---|---|
| * | K182492 | Geminus Volar Distal Radius Plate SystemSummary page 5…1 CFR §888.3030 (Primary), 21 CFR §888.3040 Regulatory Class: Class II Product Code: HRS (Primary), HWC Predicate Devices • Geminus Volar Distal Radius Plate System (K182492) Reference Device • Sponger Cable System, Modification - Pioneer Surgical Technology Inc. Sternal Cable System (K935481)… | 2018 |
| † | K935481 | Sponger Cable System, Modification | 1994 |
| † | K122310 | Geminus Fossa Specific Plate System | 2013 |
| † | K122737 | Geminus Fossa Specific Plate System | 2012 |
| † | K242436 | Proximal Humerus Fixation System | 2024 |
| † | K241815 | Protean Fragment Plating System | 2024 |
| † | K963798 | Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K182492.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Skeletal Dynamics Geminus Volar Distal Radius Plating System is intended for fixation of fractures and osteotomies of the distal radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252949: Geminus Volar Distal Radius Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252949
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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