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Paragon 28

Last updated September 17, 2026

What Paragon 28 makes

Paragon 28 manufactures orthopaedic fixation devices, including non-bioabsorbable bone screws and plates for bone stabilization, as well as fixed-bearing total ankle prostheses for joint replacement. The company also produces reusable surgical implant templates, arthrodesis intramedullary nails, and external fixation systems for fracture management. Sterilization containers for reusable devices are part of the portfolio, alongside minimally invasive bunion correction systems.

The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Paragon 28 manufacture?

Paragon 28 specializes in orthopaedic devices primarily used for bone stabilization and joint replacement. Their portfolio includes non-bioabsorbable bone screws and fixation plates for fractures, fixed-bearing total ankle prostheses for joint arthroplasty, reusable surgical implant templates, arthrodesis intramedullary nails, and external fixation systems. They also produce sterilization containers for reusable devices and minimally invasive bunion correction systems.

Where is Paragon 28 based?

Paragon 28 is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are subject to U.S. regulatory requirements, including FDA classification and UDI listing.

Which regulatory registries list Paragon 28’s devices?

Paragon 28’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices under FDA jurisdiction, including classification as Class I or Class II.

How are Paragon 28’s devices classified under FDA regulations?

Paragon 28’s devices fall into two FDA classification categories: Class I (generally low-risk devices) and Class II (devices requiring special controls to ensure safety and effectiveness). Classification depends on factors like intended use, risk level, and regulatory history, with ankle prostheses and fixation systems typically falling into Class II due to their surgical nature and potential patient risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 14445 Grasslands Dr., Englewood, CO, 80112
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008650117
DUNS Number: —

Catalogue (5858)

Page 34 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla/Gorilla Plating System	P01-911-2102	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-102-L101	FDA UDI	Class II	Active
Monster Screw System	P20-125-050F	FDA UDI	Class II	Active
Monster Screw System	P25-262-048S	FDA UDI	Class II	Active
Monster Screw System	P20-145-060L	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-199-4035-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-441-0002	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0062	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-920-TLRM	FDA UDI	Class I	Active
Tenodesis Screw System	P41-040-2000-S	FDA UDI	Class II	Active
Monster Screw System	P20-135-034S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-111-0000-07	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I416	FDA UDI	Class II	Active
Gorilla Plating System	P53-110-R002	FDA UDI	Class II	Active
Monster Screw System	P20-040-DW00	FDA UDI	Class II	Active
Gorilla Plating System	P53-101-3021	FDA UDI	Class II	Active
Dynamic Syndesmosis	P80-142-1445-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BR6S-S	FDA UDI	Class II	Active
Monster Screw System	P20-170-070M	FDA UDI	Class II	Active
AVTRAC MTP Revision System	P01-901-1301-S	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOEW-18-12 TRL	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BL3S-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-SZ06	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-810-PLF1	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-923-L301	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-115-2000-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-921-L006	FDA UDI	Class I	Active
Monster Screw System	P20-440-028F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I219	FDA UDI	Class II	Active
Patient Specific Talus Spacer	AOPSTT-XXXXS	FDA UDI	Unclassified	Active
AVTRAC MTP Revision System	P01-901-0901-S	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-R1-5556	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-PSI1	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I207-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-921-TLL2	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-440-L001	FDA UDI	Class II	Active
Gorilla Plating System	P53-101-4021	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-L2-5558	FDA UDI	Class II	Active
Monster Screw System	P26-755-090M	FDA UDI	Class II	Active
Monster Screw System	P20-135-040F	FDA UDI	Class II	Active
Monster® Screw System	P99-110-4622	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-4214	FDA UDI	Class II	Active
Monster Screw System	P20-900-0015	FDA UDI	Class I	Active
Monster Screw System	P20-570-120S	FDA UDI	Class II	Active
Monster Screw System	P25-262-056S	FDA UDI	Class II	Active
Monster Screw System	P20-155-054L	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-350-085F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-130-0044	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-239-1758	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-S1-3514	FDA UDI	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Paragon 28 has two recall records in the FDA database, both initiated in 2017 and 2018, with the earliest on December 19, 2017, and the most recent on September 28, 2018. Both records are marked as terminated. The first recall involved a wedge implant kit that was permanently mislabeled, indicating the implant was marked as a 12mm size when it was actually a 10mm size. The second recall noted a missing drill guide as stated in the package.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 28, 2018	Z-0662-2020	—	terminated	It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
Dec 19, 2017	Z-2261-2018	—	terminated	Missing drill guide as stated in the package.