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510(k) Data Aggregation
K Number
K250952Device Name
Baby Gorilla®/Gorilla® Plating System
Manufacturer
Paragon 28 Inc
Date Cleared
2025-07-18
(112 days)
Product Code
N/A
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Paragon 28 Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K231231Device Name
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
Manufacturer
Paragon 28 Inc.
Date Cleared
2023-10-12
(167 days)
Product Code
HWC, HRS, HSB, HTN, HTY, KTW
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Paragon 28 Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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, Hallux Valgus Correction, Arthrodesis/Deformity Correction, Fusion resulting from neuropathic osteoarthropathy (Charcot).
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, Mid/Hindfoot, Ankle, First metatarsal osteotomies for hallux valgus correction, Arthrodesis of the first metatarsophalangeal joint (MTP), Flatfoot, 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 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.
HammerTube™M System is indicated for fixation of The 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.
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. Components are intended for cemented use only.
Device Description
**Monster® Screw System:** The Monster® Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including fully or partially threaded self-drilling or blunt, cannulated or solid, and headed or headless. Sized-matched washers are also available.
**Baby Gorilla® / Gorilla® Plating System:** The Baby Gorilla® / Gorilla® Plating System is comprised of bone plates, threaded bone screws, and washers. Gorilla® Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non0locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla® / Gorilla® Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136).
**Phantom® Small Bone Intramedullarv Nail System:** The Phantom® Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The Phantom® nails are offered in a variety of lengths to accommodate variations in patient anatomy. The Phantom® threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varving lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.
**Phantom® Hindfoot TTC/TC Nail System:** The Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.
**HammerTube™ System:** The HammerTube™ System includes HammerTube™ and K-Wire implants. The HammerTube™ is a commercially pure titanium plasma sprayed PEEK cylinder in varying diameters, lengths, and angles. The K-Wires are stainless steel and double trocar pointed. The implants are sold sterile.
**APEX 3D Total Ankle Replacement System:** The APEX 3D™ Total Ankle Replacement System is a cemented, fixed bearing device comprised of a tibial component, a talar component and an Ultra-High Molecular Weight Polyethylene (UHMWPE) component used for ankle joint replacement. Components are available in varying sizes and design configurations intended for both primary and revision applications.
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K Number
K231496Device Name
TITAN 3-D Wedge System
Manufacturer
Paragon 28 Inc
Date Cleared
2023-08-22
(90 days)
Product Code
PLF
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Paragon 28 Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TITAN 3-D® Wedge System implants are indicated to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The TITAN 3-D® Wedge System implants are intended for use with ancillary fixation. The TITAN 3-D® Wedge System implants are not indicated for use in the spine.
Device Description
The TITAN 3-D® Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.
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K Number
K230550Device Name
JAWS Nitinol Staple System
Manufacturer
Paragon 28 Inc
Date Cleared
2023-05-11
(72 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Paragon 28 Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JAWS® Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis, and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.
Device Description
The JAWS® Nitinol Staple System are bone staples of various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile.
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