Paragon 28, Inc.
Medical device manufacturer in Centennial, CO.
60510(k) clearances
0PMA approvals
13recalls
Device types
- MBI Fastener, Fixation, Nondegradable, Soft… 13
- HRS Plate, Fixation, Bone 8
- HWC Screw, Fixation, Bone 8
- HSB Rod, Fixation, Intramedullary And Accessories 8
- HSN Prosthesis, Ankle, Semi-Constrained… 7
- KTT Appliance, Fixation, Nail/Blade/Plate… 6
- JDR Staple, Fixation, Bone 4
- HTY Pin, Fixation, Smooth 3
- PLF Bone Wedge 2
- KTW Appliance, Fixation, Nail/Blade/Plate… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | 08/28/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | 08/06/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | 08/03/2026SE |
| K253886 | Grappler Suture Anchor PCFD Tether SystemMBI · Traditional | 03/17/2026SE |
| K253591 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Traditional | 03/05/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | 12/19/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | 08/11/2025SE |
| K250952 | Baby Gorilla®/Gorilla® Plating SystemHRS · Traditional | 07/18/2025SE |
| K251850 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Special | 07/14/2025SE |
| K250641 | APEX 3D Total Ankle Replacement SystemHSN · Traditional | 05/01/2025SE |
| K242452 | Monkey Bars Pin to Bar External Fixation SystemKTT · Traditional | 11/01/2024SE |
| K234128 | Phantom Fibula Nail SystemHSB · Traditional | 08/22/2024SE |
| K241864 | Grappler Interference Screw SystemMBI · Special | 07/25/2024SE |
| K240259 | APEX 3D Total Ankle Replacement SystemHSN · Traditional | 06/24/2024SE |
| K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw SystemHRS · Special | 06/05/2024SE |
| K240594 | Grappler Suture Anchor R3FLEX IOL SystemMBI · Special | 03/26/2024SE |
| K232838 | Monkey RingsTM External Fixation SystemKTT · Special | 10/12/2023SE |
| K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…HWC · Traditional | 10/12/2023SE |
| K231496 | TITAN 3-D Wedge SystemPLF · Traditional | 08/22/2023SE |
| K231867 | Grappler Suture Anchor SystemMBI · Traditional | 08/21/2023SE |
| K230550 | JAWS Nitinol Staple SystemJDR · Traditional | 05/11/2023SE |
| K223589 | Grappler Suture Anchor R3FLEX IOL SystemMBI · Traditional | 03/03/2023SE |
| K223056 | JAWS Nitinol Staple SystemJDR · Traditional | 02/16/2023SE |
| K223184 | Phantom Metatarsal Shortening SystemHWC · Traditional | 12/16/2022SE |
| K223227 | MAVEN Patient-Specific InstrumentationHSN · Special | 11/17/2022SE |
| K222091 | Grappler Suture Anchor SystemMBI · Traditional | 09/14/2022SE |
| K222194 | Baby Gorilla®/Gorilla® Plating SystemHRS · Special | 08/19/2022SE |
| K221465 | Baby Gorilla/Gorilla Plating SystemHRS · Special | 06/17/2022SE |
| K211770 | R3ACT Stabilization SystemHWC · Traditional | 12/25/2021SE |
| K212895 | Paragon 28 External Ring Fixation SystemKTT · Traditional | 11/08/2021SE |
| K211322 | Paratrooper Plantar Plate Repair SystemMBI · Traditional | 08/30/2021SE |
| K211002 | Grappler Suture Anchor SystemMBI · Traditional | 07/07/2021SE |
| K210869 | Phantom Hindfoot TTC/TC Nail SystemHSB · Traditional | 06/28/2021SE |
| K210390 | Apex 3D Total Ankle Replacement SystemHSN · Special | 03/06/2021SE |
| K203385 | TenoTac Soft Tissue Fixation SystemMBI · Traditional | 02/11/2021SE |
| K202019 | Maven Patient-Specific InstrumentationHSN · Traditional | 01/14/2021SE |
| K203511 | Baby Gorilla/Gorilla Plating SystemHRS · Special | 12/29/2020SE |
| K203011 | Monster Screw SystemHWC · Special | 11/13/2020SE |
| K202373 | APEX 3D Total Ankle Replacement SystemHSN · Traditional | 11/13/2020SE |
| K201227 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Special | 07/17/2020SE |
| K192994 | Paragon 28 APEX 3D Total Ankle Replacement SystemHSN · Traditional | 07/10/2020SE |
| K192163 | TTC Phantom® Intramedullary Nail SystemHSB · Traditional | 01/31/2020SE |
| K191227 | Paratrooper Plantar Plate Repair SystemMBI · Traditional | 01/24/2020SE |
| K191782 | TTC Phantom Intramedullary Nail SystemHSB · Special | 09/06/2019SE |
| K190365 | Baby Gorilla/Gorilla Plating SystemHRS · Special | 04/12/2019SE |
| K190586 | Monster® Screw SystemHWC · Special | 04/03/2019SE |
| K183690 | Tenodesis Screw SystemMBI · Traditional | 03/01/2019SE |
| K183228 | HammerToe Compression SystemHTY · Traditional | 01/25/2019SE |
| K182898 | TenoTac Soft Tissue Fixation SystemMBI · Traditional | 01/14/2019SE |
| K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemHSB · Traditional | 01/14/2019SE |
| K182148 | SILVERBACK Gorilla Plating SystemHWC · Special | 09/07/2018SE |
| K171715 | HammerTube SystemHTY · Traditional | 03/05/2018SE |
| K172886 | Breakaway Screw SystemHRS · Special | 12/20/2017SE |
| K170923 | JAWS(TM) Nitinol Staple SystemJDR · Traditional | 07/24/2017SE |
| K170693 | Phantom Small Bone Intramedullary Nail SystemKTW · Traditional | 06/19/2017SE |
| K162241 | TITAN 3-D Wedge SystemPLF · Traditional | 04/03/2017SE |
| K153378 | Monster BITE Screw SystemHWC · Special | 12/21/2015SE |
| K151418 | Monster Screw SystemHWC · Special | 07/15/2015SE |
| K140397 | Paralock Plating System / Tuffnek ScrewHRS · Traditional | 04/17/2014SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2972-2026 Class III | Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number…Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels… | 07/10/2026Open, Classified |
| Z-2971-2026 Class III | Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number…Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels… | 07/10/2026Open, Classified |
| Z-2758-2026 Class II | P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod…Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch… | 06/17/2026Open, Classified |
| Z-0871-2026 Class II | Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-SFibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of… | 10/13/2025Open, Classified |
| Z-1256-2024 Class II | Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250RMedical devices distributed, prior to sterilization | 12/21/2023Open, Classified |
| Z-1255-2024 Class II | Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175LMedical devices distributed, prior to sterilization | 12/21/2023Open, Classified |
| Z-1254-2024 Class II | Phantom TTC Nail, 10.0 X 200mm, RightMedical devices distributed, prior to sterilization | 12/21/2023Open, Classified |
| Z-1776-2022 Class II | Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use…Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in… | 07/13/2022Open, Classified |
| Z-1468-2022 Class II | HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)Due to Titanium plasma coating not present implant. | 05/26/2022Open, Classified |
| Z-1458-2022 Class II | Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816…Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. | 05/18/2022Open, Classified |
| Z-2488-2021 Class II | Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630A thin wall condition between the inner cannulation and the flutes of the drill which potentially could… | 07/30/2021Terminated |
| Z-0662-2020 Class II | P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge…It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge… | 09/28/2018Terminated |
| Z-2261-2018 Class II | P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis…Missing drill guide as stated in the package. | 12/19/2017Terminated |