510(k) · Cleared
ClearedGeminus Fossa Specific Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, LLC · HRS Plate, Fixation, Bone
Cleared on Oct 3, 2012 as substantially equivalent to K111620 (Skeletal Dynamics, LLC, 2011) and 2 other predicates after a 27-day review. Its family tree reaches back 7 generations to 1996. 3 later devices descend from it.
- Decided
- Oct 3, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K962616 (1996). 10 ancestors in all. 3 later devices descend from it, 2 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 backK060864 Multidirectional Threaded PegHand Innovations, LLC · 2006
- This deviceK122737 Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC · 2012
- Descendant · cites it directly · 1 of its ownK200538 Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK242055 Freefix Forearm Plating SystemSkeletal Dynamics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK122310 Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC · 2013
Most influential descendants
Showing 3 of 3 · See all- K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc. · 2020 · cites it directly1descendant
- K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc. · 2024 · 2 generations on0descendants
- K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC · 2013 · cites it directly0descendants
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 | K060864 | Multidirectional Threaded Peg | Hand Innovations, LLC | 2006 | — |
| 0 (this device) | K122737 | Geminus Fossa Specific Plate System | Skeletal Dynamics, LLC | 2012 | — |
| +1 | K200538 | Skeletal Dynamics Forearm Plating System | Skeletal Dynamics, Inc. | 2020 | — |
| +2 | K242055 | Freefix Forearm Plating System | Skeletal Dynamics, Inc. | 2024 | — |
| +1 | K122310 | Geminus Fossa Specific Plate System | Skeletal Dynamics, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K111620 | Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right…Summary page 1…n appliances and accessories Product code: HIRS Class: Class 11 Predicate devices: Skeletal Dynamics GEMINUS Volar Distal Radius Plate (K1 11620) Synthes Titanium Alloy Volar Distal Radius Plate System (K963798) Hand Innovations Multidirectional Threaded Peg (K060864) Desc… | 2011 |
| * | K963798 | Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) SystemSummary page 1…RS Class: Class 11 Predicate devices: Skeletal Dynamics GEMINUS Volar Distal Radius Plate (K1 11620) Synthes Titanium Alloy Volar Distal Radius Plate System (K963798) Hand Innovations Multidirectional Threaded Peg (K060864) Description of the device: The Skeletal Dynamics GEMINUS Volar Distal… | 1996 |
| * | K060864 | Multidirectional Threaded PegSummary page 1…l Dynamics GEMINUS Volar Distal Radius Plate (K1 11620) Synthes Titanium Alloy Volar Distal Radius Plate System (K963798) Hand Innovations Multidirectional Threaded Peg (K060864) Description of the device: The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System contains bone plates for the repair o… | 2006 |
What descends from it? (3)
2 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 16 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K200538 (Skeletal Dynamics, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K111620.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Fossa Specific Plate 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/K122737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122737: 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/K122737
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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