510(k) · Cleared
ClearedBaby Gorilla/Gorilla Plating System; Monster Screw 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 Jun 5, 2024 as substantially equivalent to K231231 (Paragon 28, Inc., 2023) and 1 other predicate after a 30-day review. Its family tree reaches back 19 generations to 1996.
- Decided
- Jun 5, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K954385 (1996). 412 ancestors in all, the oldest K791619 (1979). No later device cites it as a predicate yet.
- Root · 19 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 15 generations between
- 3 generations backK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- 2 generations backK210869 Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · Recalled
- 1 generation backK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
- This deviceK241262 Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc. · 2024
Show all 19 generations
- Root · 19 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 18 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 17 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 16 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 15 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 14 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 13 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 12 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 11 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 10 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 9 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 8 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 7 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 6 generations backK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
- 5 generations backK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
- 4 generations backK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- 3 generations backK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- 2 generations backK210869 Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · Recalled
- 1 generation backK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
- This deviceK241262 Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −18 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −17 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −16 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −15 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −14 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −13 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −12 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −11 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −10 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −9 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −8 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −7 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| −6 | K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017 | — |
| −5 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary… | Paragon 28, Inc. | 2019 | — |
| −4 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | — |
| −3 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | — |
| −2 | K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2021 | 3 |
| −1 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic… | Paragon 28, Inc. | 2023 | — |
| 0 (this device) | K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 3 | 0 |
| 1981 | 2 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1991 | 2 | 0 |
| 1992 | 8 | 0 |
| 1993 | 5 | 0 |
| 1994 | 9 | 0 |
| 1995 | 11 | 0 |
| 1996 | 21 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 17 | 0 |
| 2000 | 22 | 0 |
| 2001 | 29 | 0 |
| 2002 | 32 | 0 |
| 2003 | 17 | 0 |
| 2004 | 15 | 0 |
| 2005 | 27 | 0 |
| 2006 | 25 | 0 |
| 2007 | 11 | 0 |
| 2008 | 14 | 0 |
| 2009 | 17 | 0 |
| 2010 | 17 | 0 |
| 2011 | 12 | 0 |
| 2012 | 8 | 0 |
| 2013 | 8 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Summary page 6…by Gorilla/Gorilla Plating System Device Class: Class II Primary Baby Gorilla/Gorilla Plating System, Monster Screw System Predicate(s): (K231231) Additional Predicate(s): Monster Screw System (K203011) Device Baby Gorilla/ Gorilla Plating System Descri… | 2023 |
| * | K203011 | Monster Screw SystemSummary page 6…Primary Baby Gorilla/Gorilla Plating System, Monster Screw System Predicate(s): (K231231) Additional Predicate(s): Monster Screw System (K203011) Device Baby Gorilla/ Gorilla Plating System Description: The Baby Gorilla/Gorilla Plating System is comprise… | 2020 |
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 28 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 105 of the 412 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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. The…
Read the full statement (560 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 (TMT) Fusions
* Intercuneiform Fusions
* Navicular-Cuneiform (NC) Fusion
* Talo-Navicular (TN) Fusion
* Calcaneo-Cuboid (CC) Fusion
* Subtalar Fusion
* Medial Column Fusion
* 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 MalleolarAvulsion 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.
The Monster Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include:
Fractures and Osteotomies
* Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
* Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
* Talar fractures
* Ankle fractures
* Navicular fractures
* Fractures of the fibula, malleolus, and calcaneus
* Metatarsal and phalangeal osteotomies
* Weil osteotomy
* Calcaneal osteotomy
Hallux Valgus Correction
* Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
* Interphalangeal (IP) arthrodesis
* Proximal, midshaft, or distal osteotomy
* Lapidus arthrodesis
Arthrodesis/Deformity Correction
* 1st MTP arthrodesis
* Metatarsal deformity correction
* Tarsometatarsal joint arthrodesis
* Naviculocuneiform joint arthrodesis
* Talonavicular arthrodesis
* Subtalar joint arthrodesis
* Triple arthrodesis
* Medial column arthrodesis
* Subtalar joint distraction arthrodesis
*Ankle arthrodesis
* Lateralizing calcaneal osteotomy
* Lateral column lengthening
* Hammertoe
Fusion resulting from neuropathic osteoarthropathy (Charcot) such as:
* Medial and lateral column
* Subtalar, talonavicular, and calcaneocuboid
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241262: Baby Gorilla/Gorilla Plating System; Monster Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241262
Report an extraction error
Are you the manufacturer?
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