# K241262: Baby Gorilla/Gorilla Plating System; Monster Screw System

- Pathway: 510(k) (Special)
- Applicant: Paragon 28, Inc.
- Decided: Jun 5, 2024 after 30 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K954385 (1996). 412 ancestors in all.
No later device cites it as a predicate yet.
0 of 413 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices, Paragon 28, Inc. (2023) Summary page 6.
- K203011: Monster Screw System, Paragon 28, Inc. (2020) Summary page 6.

## Indications for use
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

Source page: https://510kreport.com/device/K241262
Methodology: https://510kreport.com/methodology