510(k) Report

510(k) · Cleared

Cleared

Geminus Volar Distal Radius Plate System

K182492510(k) SpecialCleared Oct 10, 201829-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Skeletal Dynamics, LLC · HRS Plate, Fixation, Bone

Cleared on Oct 10, 2018 as substantially equivalent to K111620 (Skeletal Dynamics, LLC, 2011) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.

Decided
Oct 10, 2018
Review
29 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K963798 (1996). 3 ancestors in all. 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2025: 2 descendants cleared2021: 2 descendants cleared2024: 1 descendant cleared2022: 1 descendant clearedK963798 · Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System · Synthes (Usa) · 1996K111620 · Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right, Standard 3 Hole Left, Skeletal Dynamics · Skeletal Dynamics, LLC · 20111995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 2 descendants K111620 · Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right, Standard 3 Hole Left, Skeletal Dynamics · Skeletal Dynamics, LLC · 2011K963798 · Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System · Synthes (Usa) · 19960
  1. Root · 2 generations backK963798 Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP)…Synthes (Usa) · 1996
  2. 1 generation backK111620 Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3…Skeletal Dynamics, LLC · 2011
  3. This deviceK182492 Geminus Volar Distal Radius Plate SystemSkeletal Dynamics, LLC · 2018
  4. Descendant · cites it directly · 2 of its ownK202971 DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2021
  5. Descendant · cites it directly · 0 of its ownK252949 Geminus Volar Distal Radius Plating SystemSkeletal Dynamics, Inc. · 2025
  6. Descendant · cites it directly · 0 of its ownK251361 Tyber Medical Distal Radius Plating SystemTyber Medical, LLC · 2025
  7. Descendant · 2 generations on · 0 of its ownK233531 OIC FLEX-FIX™ SystemOrthopaedic Implant Company · 2024
  8. Descendant · 2 generations on · 0 of its ownK212601 DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2022

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2021: 22022: 12024: 12025: 2
2021high 2 (2021) · low 0 (2023)2026

Most influential descendants

Showing 5 of 6 · See all
  • K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2021 · cites it directly2descendants
  • K252949Geminus Volar Distal Radius Plating SystemSkeletal Dynamics, Inc. · 2025 · cites it directly0descendants
  • K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC · 2025 · cites it directly0descendants
  • K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company · 2024 · 2 generations on0descendants
  • K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K963798Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) SystemSynthes (Usa)1996—
−1K111620Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole…Skeletal Dynamics, LLC2011—
0 (this device)K182492Geminus Volar Distal Radius Plate SystemSkeletal Dynamics, LLC2018—
+1K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company2021—
+1K252949Geminus Volar Distal Radius Plating SystemSkeletal Dynamics, Inc.2025—
+1K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC2025—
+2K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company2024—
+2K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202120
202210
202410
202520
FIG. 1 — Lineage of K182492, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K111620Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right…
Summary page 4
…ation, Bone Classification 21 CFR §888.3030 Product Code HRS Class Class II Predicate Devices: Primary: Geminus Volar Distal Radius Plate System (K111620) Synthes LCP Diaphyseal-metaphyseal (dia-meta) Volar Distal Radius Plate (K070946) Description of the Device: The Sk…
Skeletal Dynamics, LLC2011—
*K070946Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates
Summary page 4
…lass II Predicate Devices: Primary: Geminus Volar Distal Radius Plate System (K111620) Synthes LCP Diaphyseal-metaphyseal (dia-meta) Volar Distal Radius Plate (K070946) Description of the Device: The Skeletal Dynamics Geminus Volar Distal Radius Plate System contains bone plates for the repai…
Synthes (Usa)20071

Also cleared against K111620: 3 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212
K252949Geminus Volar Distal Radius Plating SystemSkeletal Dynamics, Inc.20250
K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250
K213214Xpert WristNewclip Technics20210

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 22 years and passes through 2 companies; a new generation was cleared every 14.7 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K202971 (Orthopaedic Implant Company, 2021) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K111620.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation

of fractures and osteotomies of the distal radius

Indications for use as stated in the FDA summary.

Also cleared against K111620

3 other devices cite the same predicate.

  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  • K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC · 2013
  • K122737Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC · 2012

More from Skeletal Dynamics, LLC

18 FDA decisions under this applicant name. See the company

  • K180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLC · 2018
  • K172688Align Radial Head SystemSkeletal Dynamics, LLC · 2017
  • K171590Distal Elbow Plating SystemSkeletal Dynamics, LLC · 2017
  • K153208Internal Joint Stabilizer - ElbowSkeletal Dynamics, LLC · 2015
  • K150675Dorsal Spanning PlateSkeletal Dynamics, LLC · 2015

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K182492 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182492: Geminus Volar Distal Radius Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182492

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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