510(k) · Cleared
ClearedBaby Gorilla/Gorilla Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · HRS Plate, Fixation, Bone
Cleared on Apr 12, 2019 after a 56-day review. The FDA summary names no predicate by number. 36 later devices descend from it.
- Decided
- Apr 12, 2019
- Review
- 56 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 6 citing it directly.
- This deviceK190365 Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 2019
- Descendant · cites it directly · 17 of its ownK203511 Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 2020
- Descendant · cites it directly · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- Descendant · 2 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
- Descendant · 2 generations on · 6 of its ownK221465 Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 2022
- Descendant · 3 generations on · 5 of its ownK222194 Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc. · 2022
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K203511Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 2020 · cites it directly17descendants
- K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · cites it directly10descendants
- K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 2 generations on9descendants
- K221465Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 2022 · 2 generations on6descendants
- K222194Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc. · 2022 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190365 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | 2019 | — |
| +1 | K203511 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | 2020 | — |
| +1 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
| +2 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | — |
| +2 | K221465 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | 2022 | — |
| +3 | K222194 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 10 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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?
The FDA summary names no predicate by number.
What descends from it? (36)
See all 366 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?
- Of its descendants, K203511 (Paragon 28, Inc., 2020) has gone furthest, with 17 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 | — |
https://510kreport.com/device/K190365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190365: Baby Gorilla/Gorilla 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/K190365
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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