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 Dec 29, 2020 as substantially equivalent to K190365 (Paragon 28, Inc., 2019) after a 29-day review. Its family tree reaches back 1 generation to 2019. 17 later devices descend from it.
- Decided
- Dec 29, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K190365 (2019). 17 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK190365 Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 2019
- This deviceK203511 Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK221465 Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 2022
- Descendant · 2 generations on · 5 of its ownK222194 Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK211770 R3ACT Stabilization SystemParagon 28, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK250952 Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc. · 2025
- Descendant · 2 generations on · 2 of its ownK223589 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K221465Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 2022 · cites it directly6descendants
- K222194Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc. · 2022 · 2 generations on5descendants
- K211770R3ACT Stabilization SystemParagon 28, Inc. · 2021 · cites it directly3descendants
- K250952Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc. · 2025 · cites it directly2descendants
- K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K190365 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | 2019 | — |
| 0 (this device) | K203511 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | 2020 | — |
| +1 | K221465 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | 2022 | — |
| +2 | K222194 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2022 | — |
| +1 | K211770 | R3ACT Stabilization System | Paragon 28, Inc. | 2021 | — |
| +1 | K250952 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2025 | — |
| +2 | K223589 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K190365 | Baby Gorilla/Gorilla Plating SystemSummary page 5…HRS, HWC, HTN Common Name: Bone Plate, Bone Screw, Bone Washer Predicate Device: Baby Gorilla®/Gorilla® Plating System (K190365) Indications for Use: The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Gorilla® Plati… | 2019 |
What descends from it? (17)
See all 176 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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists.…
Read the full statement (382 words)
The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both adult and pediatric patients. Specific examples include:
Forefoot:
* Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
* Metatarsal or phalangeal fractures and osteotomies
* Lesser metatarsal shortening osteotomies (e.g. Weil)
* Fifth metatarsal fractures (e.g. Jones Fracture)
Mid/Hindfoot:
* LisFranc Arthrodesis and/or Stabilization
* 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal ('MT) Fusions
* Intercuneiform Fusions
* Navicular-Cuneiform (NC) Fusion
* Talo-Navicular (TN) Fusion
* Calcaneo-Cuboid (CC) Fusion
* Subtalar Fusion
* Medial Column Fusions
* Cuneiform Fracture
* Cuboid Fracture
* Navicular Fracture
Ankle:
* Lateral Malleolar Fractures
* Syndesmosis Injuries
* Medial Malleolar Fractures and Osteotomies
* Bi-Malleolar Fractures
* Tri-Malleolar Fractures
* Posterior Malleolar Fractures
* Distal Anterior Tibia Fractures
* Vertical Shear Fractures of the Medial Malleolus
* Pilon Fractures
* Distal Tibia Shaft Fractures
* Distal Fibula Shaft Fractures
* Distal Tibia Periarticular Fractures
* Medial Malleolar Avulsion Fractures
* Lateral Malleolar Avulsion Fractures
* Tibiotalocalcaneal Joint Arthrodesis
* Tibiotalar Joint Arthrodesis
* Tibiocalcaneal Arthrodesis
* Supramalleolar Osteotomy
* Fibular Osteotomy
First metatarsal osteotomies for hallux valgus correction including:
* Opening base wedge osteotomy
* Closing base wedge osteotomy
* Crescentic Osteotomy
* Proximal Osteotomy (Chevron and Rotational Oblique)
* Distal Osteotomy (Chevron/Austin)
Arthrodesis of the first metatarsophalangeal joint (MTP) including:
* Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
* Revision MTP Fusion
* Revision of failed first MTP Arthroplasty implant
Flatfoot:
* Lateral Column Lengthening (Evans Osteotomy)
* Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
* Calcaneal Slide Osteotomy
Charcot:
* Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot)
* Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)
In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203511: Baby Gorilla/Gorilla Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203511
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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