Is this your brand? Sign in to claim ownership.

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 93 of 118

Device	Model / Reference	Registries	Class	Status
APEX 3D Total Ankle Replacement System	P10-101-BR3S-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BR1S-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-250-TLR4-S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-810-TUA5	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-630-175R-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P99-100-2010	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P51-920-1012	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I520	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-330-1050	FDA UDI	Class II	Active
Monster Screw System	P26-555-065F	FDA UDI	Class II	Active
R3ACT Stabilization System	P80-940-3903	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-140-0070	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-2734	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-L2-5544	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I106-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-900-LID	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-106-R101	FDA UDI	Class II	Active
Gorilla Plating System	P53-106-L002	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I408-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I111	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-955-0085	FDA UDI	Class I	Active
HammerTube System	P40-910-3500	FDA UDI	Class I	Active
Gorilla Plating System	P53-101-2013	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-517-0001	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-553-4555	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-NCFS-1	FDA UDI	Class I	Active
Monster Screw System	P25-262-054S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-906-EXTT-1	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	PMT-2105	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-251-TLL1-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-4520	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-CAD-BAS2	FDA UDI	Class I	Active
Monster Screw System	P24-020-011S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-800-150R-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-109-R301	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2519	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-210-420S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-920-0004	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-100-0003	FDA UDI	Class II	Active
R3ACT Stabilization System	P99-000-TQ08	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-011-R101	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-421-L202	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-3530	FDA UDI	Class II	Active
Grappler Interference Screw System	P62-197-1620	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOCW-TRL-20-4.5	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I516-S	FDA UDI	Class II	Active
Dynamic Syndesmosis	P80-142-1750-S	FDA UDI	Class II	Active
Monster Screw System	P20-070-WD00	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-851-GR01	FDA UDI	Class I	Active
Dynamic Syndesmosis	P80-142-1470-S	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.