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Paragon 28

Last updated September 17, 2026

Information

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

Catalogue (5858)

Page 117 of 118

Device	Model / Reference	Registries	Class	Status
Precision MIS Bunion System	P99-150-2704	FDA UDI	Class I	Active
TenoTac Soft Tissue Fixation System	K182898	FDA 510(k)	Class II	Active
Phantom Metatarsal Shortening System	K223184	FDA 510(k)	Class II	Active
TITAN 3-D™ Wedge System	K162241	FDA 510(k)	Class II	Active
Phantom Small Bone Intramedullary Nail System	K170693	FDA 510(k)	Class II	Active
TTC Phantom® Intramedullary Nail System	K192163	FDA 510(k)	Class II	Active
APEX 3D Total Ankle Replacement System	K250641	FDA 510(k)	Class II	Active
Phantom Fibula Nail System	K234128	FDA 510(k)	Class II	Active
Breakaway Screw System	K172886	FDA 510(k)	Class II	Active
Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System	K182307	FDA 510(k)	Class II	Active
Phantom Hindfoot TTC/TC Nail System	K210869	FDA 510(k)	Class II	Active
Grappler Suture Anchor System	K211002	FDA 510(k)	Class II	Active
Phantom® Hindfoot TTC/TC Nail System	K201227	FDA 510(k)	Class II	Active
Baby Gorilla/Gorilla Plating System; Monster Screw System	K241262	FDA 510(k)	Class II	Active
External Fixation Bone Distractor	K251862	FDA 510(k)	Class II	Active
Monster Screw System	K203011	FDA 510(k)	Class II	Active
JAWS(TM) Nitinol Staple System	K170923	FDA 510(k)	Class II	Active
Baby Gorilla®/Gorilla® Plating System	K222194	FDA 510(k)	Class II	Active
HammerTube System	K171715	FDA 510(k)	Class II	Active
Phantom® Hindfoot TTC/TC Nail System	K253591	FDA 510(k)	Class II	Active
Baby Gorilla/Gorilla Plating System	K203511	FDA 510(k)	Class II	Active
TTC Phantom Intramedullary Nail System	K191782	FDA 510(k)	Class II	Active
Grappler Interference Screw System	K241864	FDA 510(k)	Class II	Active
Grappler Suture Anchor PCFD Tether System	K253886	FDA 510(k)	Class II	Active
Monkey Bars Pin to Bar External Fixation System	K242452	FDA 510(k)	Class II	Active
R3ACT Stabilization System	K211770	FDA 510(k)	Class II	Active
Grappler Suture Anchor R3FLEX IOL System	K240594	FDA 510(k)	Class II	Active
TITAN 3-D Wedge System	K231496	FDA 510(k)	Class II	Active
Paratrooper Plantar Plate Repair System	K211322	FDA 510(k)	Class II	Active
JAWS Nitinol Staple System	K223056	FDA 510(k)	Class II	Active
Grappler Suture Anchor R3FLEX IOL System	K223589	FDA 510(k)	Class II	Active
MAVEN™ Patient-Specific Instrumentation	K223227	FDA 510(k)	Class II	Active
Paragon 28 External Ring Fixation System	K212895	FDA 510(k)	Class II	Active
APEX 3D Total Ankle Replacement System	K202373	FDA 510(k)	Class II	Active
Tenodesis Screw System	K183690	FDA 510(k)	Class II	Active
Paragon 28 APEX 3D Total Ankle Replacement System	K192994	FDA 510(k)	Class II	Active
Monster® Screw System	K190586	FDA 510(k)	Class II	Active
TenoTac Soft Tissue Fixation System	K203385	FDA 510(k)	Class II	Active
APEX 3D Total Ankle Replacement System	K240259	FDA 510(k)	Class II	Active
Maven Patient-Specific Instrumentation	K202019	FDA 510(k)	Class II	Active
Paralock Plating System / Tuffnek Screw	K140397	FDA 510(k)	Class II	Active
Phantom® Hindfoot TTC/TC Nail System	K251850	FDA 510(k)	Class II	Active
Paratrooper Plantar Plate Repair System	K191227	FDA 510(k)	Class II	Active
External Fixation Mini Rail System	K252106	FDA 510(k)	Class II	Active
SILVERBACK Gorilla Plating System	K182148	FDA 510(k)	Class II	Active
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices	K231231	FDA 510(k)	Class II	Active
Grappler Suture Anchor System	K222091	FDA 510(k)	Class II	Active
JAWS Nitinol Staple System	K230550	FDA 510(k)	Class II	Active
Apex 3D Total Ankle Replacement System	K210390	FDA 510(k)	Class II	Active
Monster Screw System	K151418	FDA 510(k)	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.

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.