# K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Oct 12, 2023 after 167 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K954385 (1996). 411 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 413 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203011: Monster Screw System, Paragon 28, Inc. (2020) Summary page 12.
- K222194: Baby Gorilla®/Gorilla® Plating System, Paragon 28, Inc. (2022) Summary page 12.
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System, Paragon 28, Inc. (2019) Summary page 12.
- K210869: Phantom Hindfoot TTC/TC Nail System, Paragon 28, Inc. (2021) Summary page 12.
- K171715: HammerTube System, Paragon 28 (2018) Summary page 12.
- K210390: Apex 3D Total Ankle Replacement System, Paragon 28, Inc. (2021) Summary page 12.

## Most influential descendants
- K241262: Baby Gorilla/Gorilla Plating System; Monster Screw System (2024), 0 descendants of its own

## Indications for use
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 The Baby Gorilla® / Gorilla® Bone Plates and Bone Screws of the Baby Gorilla® and 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 fractures (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 Malleolar Avulsion Fractures * Tibiotalocalcaneal 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 Lengthing (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 Phantom® Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures. The Phantom® Hindfoot TTC/TC Nail System is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: * Post-traumatic or degenerative arthritis * Previously infected arthrosis * Revision of failed ankle arthrodesis * Revision of failed total ankle arthroplasty * Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis) * Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle * Rheumatoid arthritis * Osteoarthritis * Nonunions or pseudarthrosis of hindfoot and distal tibia * Trauma (severe or malunited tibial pilon fracture) * Charcot foot (neuroarthropathy) * Severe end-stage degenerative arthritis * Instability and skeletal defects after tumor resection * Pantalar arthrodesis * Severe foot/ankle deformity The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: * Post-traumatic or degenerative arthritis * Previously infected arthrosis * Revision of failed ankle arthrodesis * Revision of failed total ankle arthroplasty * Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis) * Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle * Rheumatoid arthritis * Osteoarthritis * Nonunions or pseudarthrosis of hindfoot and distal tibia * Trauma (severe or malunited tibial pilon fracture) * Charcot foot (neuroarthropathy) * Severe end-stage degenerative arthritis * Instability and skeletal defects after tumor resection * Pantalar arthrodesis * Severe foot/ankle deformity The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only. The HammerTube™ System is indicated for fixation of reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures. The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-Wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint. The implantable K-Wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-Wires are indicated as guide pines for insertion of instruments and implants in the HammerTube™ System.

Source page: https://510kreport.com/device/K231231
Methodology: https://510kreport.com/methodology