Paragon 28, Inc.
Paragon 28, Inc. holds FDA 510(k) medical device clearances, first cleared 2017, most recent 2026, with 13 FDA device recalls on record.
Top product codes for Paragon 28, Inc.
FDA recalls by Paragon 28, Inc.
10 most recent of 13- Z-2971-2026 — Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
- Z-2972-2026 — Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
- Z-2758-2026 — P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
- Z-0871-2026 — Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
- Z-1254-2024 — Phantom TTC Nail, 10.0 X 200mm, Right
- Z-1256-2024 — Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
- Z-1255-2024 — Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
- Z-1776-2022 — Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
- Z-1468-2022 — HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
- Z-1458-2022 — Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Paragon 28, Inc.
- K262722 — Primal K-Wire (P99-193-1410)
- K261121 — Megalodon Dynamic Compression System
- K262047 — Grappler Suture Anchor System
- K253886 — Grappler Suture Anchor PCFD Tether System
- K253591 — Phantom® Hindfoot TTC/TC Nail System
- K253613 — Monkey Rings External Ring Fixation System
- K252106 — External Fixation Mini Rail System
- K251862 — External Fixation Bone Distractor
- K250952 — Baby Gorilla®/Gorilla® Plating System
- K251850 — Phantom® Hindfoot TTC/TC Nail System
- K250641 — APEX 3D Total Ankle Replacement System
- K242452 — Monkey Bars Pin to Bar External Fixation System
- K234128 — Phantom Fibula Nail System
- K241864 — Grappler Interference Screw System
- K240259 — APEX 3D Total Ankle Replacement System
- K241262 — Baby Gorilla/Gorilla Plating System; Monster Screw System
- K240594 — Grappler Suture Anchor R3FLEX IOL System
- K231231 — MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
- K232838 — Monkey RingsTM External Fixation System
- K231496 — TITAN 3-D Wedge System
- K231867 — Grappler Suture Anchor System
- K230550 — JAWS Nitinol Staple System
- K223589 — Grappler Suture Anchor R3FLEX IOL System
- K223056 — JAWS Nitinol Staple System
- K223184 — Phantom Metatarsal Shortening System
- K223227 — MAVEN Patient-Specific Instrumentation
- K222091 — Grappler Suture Anchor System
- K222194 — Baby Gorilla®/Gorilla® Plating System
- K221465 — Baby Gorilla/Gorilla Plating System
- K211770 — R3ACT Stabilization System
- K212895 — Paragon 28 External Ring Fixation System
- K211322 — Paratrooper Plantar Plate Repair System
- K211002 — Grappler Suture Anchor System
- K210869 — Phantom Hindfoot TTC/TC Nail System
- K210390 — Apex 3D Total Ankle Replacement System
- K203385 — TenoTac Soft Tissue Fixation System
- K202019 — Maven Patient-Specific Instrumentation
- K203511 — Baby Gorilla/Gorilla Plating System
- K202373 — APEX 3D Total Ankle Replacement System
- K203011 — Monster Screw System
- K201227 — Phantom® Hindfoot TTC/TC Nail System
- K192994 — Paragon 28 APEX 3D Total Ankle Replacement System
- K192163 — TTC Phantom® Intramedullary Nail System
- K191227 — Paratrooper Plantar Plate Repair System
- K191782 — TTC Phantom Intramedullary Nail System
- K190365 — Baby Gorilla/Gorilla Plating System
- K190586 — Monster® Screw System
- K183690 — Tenodesis Screw System
- K183228 — HammerToe Compression System
- K182307 — Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System
- K182898 — TenoTac Soft Tissue Fixation System
- K182148 — SILVERBACK Gorilla Plating System
- K170693 — Phantom Small Bone Intramedullary Nail System
Data sourced from openFDA. This site is unofficial and independent of the FDA.