Englewood, CO, US · 43 510(k) clearances · 9 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | 11 | 2026-08-03 |
| HSN | — | — | — | 7 | 2025-05-01 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | 6 | 2026-03-05 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | 6 | 2025-12-19 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 5 | 2025-07-18 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 4 | 2023-10-12 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | 3 | 2026-08-06 |
| PLF | Bone Wedge | Class II | Orthopedic | 1 | 2023-08-22 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-06-17 | Class II | Ongoing | Z-2758-2026 | P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, I… | — | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. |
| 2025-10-13 | Class II | Ongoing | Z-0871-2026 | Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S | — | Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may … |
| 2023-12-21 | Class II | Ongoing | Z-1256-2024 | Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R | — | Medical devices distributed, prior to sterilization |
| 2023-12-21 | Class II | Ongoing | Z-1255-2024 | Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L | — | Medical devices distributed, prior to sterilization |
| 2023-12-21 | Class II | Ongoing | Z-1254-2024 | Phantom TTC Nail, 10.0 X 200mm, Right | — | Medical devices distributed, prior to sterilization |
| 2022-07-13 | Class II | Ongoing | Z-1776-2022 | Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anch… | — | Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. |
| 2022-05-26 | Class II | Ongoing | Z-1468-2022 | HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile) | — | Due to Titanium plasma coating not present implant. |
| 2022-05-18 | Class II | Ongoing | Z-1458-2022 | Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill,… | — | Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. |
| 2021-07-30 | Class II | Terminated | Z-2488-2021 | Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630 | — | A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the ca… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-06 | K261121 | Megalodon Dynamic Compression System | JDR | Class II | Orthopedic |
| 2026-08-03 | K262047 | Grappler Suture Anchor System | MBI | Class II | Orthopedic |
| 2026-03-17 | K253886 | Grappler Suture Anchor PCFD Tether System | MBI | Class II | Orthopedic |
| 2026-03-05 | K253591 | Phantom® Hindfoot TTC/TC Nail System | HSB | Class II | Orthopedic |
| 2025-12-19 | K253613 | Monkey Rings External Ring Fixation System | KTT | Class II | Orthopedic |
| 2025-09-30 | K252106 | External Fixation Mini Rail System | KTT | Class II | Orthopedic |
| 2025-08-11 | K251862 | External Fixation Bone Distractor | KTT | Class II | Orthopedic |
| 2025-07-18 | K250952 | Baby Gorilla®/Gorilla® Plating System | HRS | Class II | Orthopedic |
| 2025-07-14 | K251850 | Phantom® Hindfoot TTC/TC Nail System | HSB | Class II | Orthopedic |
| 2025-05-01 | K250641 | APEX 3D Total Ankle Replacement System | HSN | — | — |
| 2024-11-01 | K242452 | Monkey Bars Pin to Bar External Fixation System | KTT | Class II | Orthopedic |
| 2024-08-22 | K234128 | Phantom Fibula Nail System | HSB | Class II | Orthopedic |
| 2024-07-25 | K241864 | Grappler Interference Screw System | MBI | Class II | Orthopedic |
| 2024-06-24 | K240259 | APEX 3D Total Ankle Replacement System | HSN | — | — |
| 2024-06-05 | K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | HRS | Class II | Orthopedic |
| 2024-03-26 | K240594 | Grappler Suture Anchor R3FLEX IOL System | MBI | Class II | Orthopedic |
| 2023-10-12 | K232838 | Monkey RingsTM External Fixation System | KTT | Class II | Orthopedic |
| 2023-10-12 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices | HWC | Class II | Orthopedic |
| 2023-08-22 | K231496 | TITAN 3-D Wedge System | PLF | Class II | Orthopedic |
| 2023-08-21 | K231867 | Grappler Suture Anchor System | MBI | Class II | Orthopedic |
| 2023-05-11 | K230550 | JAWS Nitinol Staple System | JDR | Class II | Orthopedic |
| 2023-03-03 | K223589 | Grappler Suture Anchor R3FLEX IOL System | MBI | Class II | Orthopedic |
| 2023-02-16 | K223056 | JAWS Nitinol Staple System | JDR | Class II | Orthopedic |
| 2022-12-16 | K223184 | Phantom Metatarsal Shortening System | HWC | Class II | Orthopedic |
| 2022-11-17 | K223227 | MAVEN Patient-Specific Instrumentation | HSN | — | — |
| 2022-09-14 | K222091 | Grappler Suture Anchor System | MBI | Class II | Orthopedic |
| 2022-08-19 | K222194 | Baby Gorilla®/Gorilla® Plating System | HRS | Class II | Orthopedic |
| 2022-06-17 | K221465 | Baby Gorilla/Gorilla Plating System | HRS | Class II | Orthopedic |
| 2021-12-25 | K211770 | R3ACT Stabilization System | HWC | Class II | Orthopedic |
| 2021-11-08 | K212895 | Paragon 28 External Ring Fixation System | KTT | Class II | Orthopedic |
| 2021-08-30 | K211322 | Paratrooper Plantar Plate Repair System | MBI | Class II | Orthopedic |
| 2021-07-07 | K211002 | Grappler Suture Anchor System | MBI | Class II | Orthopedic |
| 2021-06-28 | K210869 | Phantom Hindfoot TTC/TC Nail System | HSB | Class II | Orthopedic |
| 2021-03-06 | K210390 | Apex 3D Total Ankle Replacement System | HSN | — | — |
| 2021-02-11 | K203385 | TenoTac Soft Tissue Fixation System | MBI | Class II | Orthopedic |
| 2021-01-14 | K202019 | Maven Patient-Specific Instrumentation | HSN | — | — |
| 2020-12-29 | K203511 | Baby Gorilla/Gorilla Plating System | HRS | Class II | Orthopedic |
| 2020-11-13 | K203011 | Monster Screw System | HWC | Class II | Orthopedic |
| 2020-11-13 | K202373 | APEX 3D Total Ankle Replacement System | HSN | — | — |
| 2020-07-17 | K201227 | Phantom® Hindfoot TTC/TC Nail System | HSB | Class II | Orthopedic |
| 2020-07-10 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | HSN | — | — |
| 2020-01-31 | K192163 | TTC Phantom® Intramedullary Nail System | HSB | Class II | Orthopedic |
| 2020-01-24 | K191227 | Paratrooper Plantar Plate Repair System | MBI | Class II | Orthopedic |