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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 33 of 118

Device	Model / Reference	Registries	Class	Status
APEX 3D Total Ankle Replacement System	P10-902-2450	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-109-L213	FDA UDI	Class II	Active
Monster Screw System	P20-525-040S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-230-2000-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-2709	FDA UDI	Class II	Active
FJ2000 System	P65-001-0007-SK	FDA UDI	Class I	Active
Monster Screw System	P20-900-INSK	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-153-2536	FDA UDI	Class II	Active
Monster Screw System	P20-570-078L	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-110F	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-4216	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I319	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P01-911-1902	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-180-BR3S-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I320-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I208-S	FDA UDI	Class II	Active
Tenodesis Screw System	P41-045-1500-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-002-LC83	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I213-S	FDA UDI	Class II	Active
Monster Screw System	P20-931-7000	FDA UDI	Class I	Active
Monster Screw System	P20-570-038S	FDA UDI	Class II	Active
Grappler Interference Screw System	P41-942-5560	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-854-D12S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-4560	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-150-0011	FDA UDI	Class I	Active
TITAN 3-D Wedge System	P03-940-9001	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-2755	FDA UDI	Class II	Active
Gorilla Plating System	P50-900-0002	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-135-0048	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-130-0042	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-851-TP34	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-112-2001	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-903-TRY1	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-942-35TH	FDA UDI	Class I	Active
Monster Screw System	P20-570-125M	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4270	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-3528	FDA UDI	Class II	Active
Monster Screw System	P20-120-008F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I406-S	FDA UDI	Class II	Active
Monster Screw System	P26-550-070M	FDA UDI	Class II	Active
Monster Screw System	P20-427-038F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-103-R054	FDA UDI	Class II	Active
Monster Screw System	P20-135-010S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-100-3813	FDA UDI	Class I	Active
Bun-Yo-Matic™ Lapidus Clamp System	P30-960-1212R	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-753-3532	FDA UDI	Class II	Active
Monster Screw System	P25-440-050S	FDA UDI	Class II	Active
Tenodesis Screw System	P41-080-2500-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-901-RGA2	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-931-I318	FDA UDI	Class II	Active

Related Companies

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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.