510(k) Report

510(k) · Cleared

Cleared

Geminus Fossa Specific Plate System

K122310510(k) TraditionalCleared Jan 18, 2013170-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 Jan 18, 2013 as substantially equivalent to K111620 (Skeletal Dynamics, LLC, 2011) and 3 other predicates after a 170-day review. Its family tree reaches back 8 generations to 1996.

Decided
Jan 18, 2013
Review
170 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K962616 (1996). 12 ancestors in all, the oldest K951303 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor2000: 1 other ancestorK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK060864 · Multidirectional Threaded Peg · Hand Innovations, LLC · 2006K122737 · Geminus Fossa Specific Plate System · Skeletal Dynamics, LLC · 201219952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors7 generations back: 1 other ancestor K122737 · Geminus Fossa Specific Plate System · Skeletal Dynamics, LLC · 2012K060864 · Multidirectional Threaded Peg · Hand Innovations, LLC · 2006K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−50
  1. Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 2 generations backK060864 Multidirectional Threaded PegHand Innovations, LLC · 2006
  8. 1 generation backK122737 Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC · 2012
  9. This deviceK122310 Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−7K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−6K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−5K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−4K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−3K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−2K060864Multidirectional Threaded PegHand Innovations, LLC2006—
−1K122737Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC2012—
0 (this device)K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
200010
201110
FIG. 1 — Lineage of K122310, 1996–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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 1
…on Appliances and Accessories Product code: HRS Class: Class 11 Predicate devices: Skeletal Dynamics GEMINUS Volar Distal Radius Plate (K1 11620, K122737), Synthes Distal Radius Plate (K963798), and Medpac SFC (K951303) Description of the device: The Gem inus Volar Distal…
Skeletal Dynamics, LLC2011—
*K122737Geminus Fossa Specific Plate System
Cleared while this submission was under review
Summary page 1
…Appliances and Accessories Product code: HRS Class: Class 11 Predicate devices: Skeletal Dynamics GEMINUS Volar Distal Radius Plate (K1 11620, K122737), Synthes Distal Radius Plate (K963798), and Medpac SFC (K951303) Description of the device: The Gem inus Volar Distal Radius Pl…
Skeletal Dynamics, LLC2012—
*K963798Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System
Summary page 1
…roduct code: HRS Class: Class 11 Predicate devices: Skeletal Dynamics GEMINUS Volar Distal Radius Plate (K1 11620, K122737), Synthes Distal Radius Plate (K963798), and Medpac SFC (K951303) Description of the device: The Gem inus Volar Distal Radius Plate System contains bone plates for the…
Synthes (Usa)1996—
*K951303SFC
Summary page 1
…: Class 11 Predicate devices: Skeletal Dynamics GEMINUS Volar Distal Radius Plate (K1 11620, K122737), Synthes Distal Radius Plate (K963798), and Medpac SFC (K951303) Description of the device: The Gem inus Volar Distal Radius Plate System contains bone plates for the repair of distal volar ra…
Medpac1995—

Also cleared against K111620: 3 other devices →

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 17 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • 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. 2013, 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.

  • K182492Geminus Volar Distal Radius Plate SystemSkeletal Dynamics, LLC · 2018
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  • K122737Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC · 2012

More from Skeletal Dynamics, LLC

18 FDA decisions under this applicant name. See the company

  • K182492Geminus Volar Distal Radius Plate SystemSkeletal Dynamics, LLC · 2018
  • 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

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/K122310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122310: Geminus Fossa Specific 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/K122310

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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