| Megalodon Dynamic Compression System (K261121) | Paragon 28, Inc. | 2026-08-06 |
| Grappler Suture Anchor System (K262047) | Paragon 28, Inc. | 2026-08-03 |
| Grappler Suture Anchor PCFD Tether System (K253886) | Paragon 28, Inc. | 2026-03-17 |
| Phantom® Hindfoot TTC/TC Nail System (K253591) | Paragon 28, Inc. | 2026-03-05 |
| Monkey Rings External Ring Fixation System (K253613) | Paragon 28, Inc. | 2025-12-19 |
| External Fixation Mini Rail System (K252106) | Paragon 28, Inc. | 2025-09-30 |
| External Fixation Bone Distractor (K251862) | Paragon 28, Inc. | 2025-08-11 |
| Baby Gorilla®/Gorilla® Plating System (K250952) | Paragon 28, Inc. | 2025-07-18 |
| Phantom® Hindfoot TTC/TC Nail System (K251850) | Paragon 28, Inc. | 2025-07-14 |
| APEX 3D Total Ankle Replacement System (K250641) | Paragon 28, Inc. | 2025-05-01 |
| Monkey Bars Pin to Bar External Fixation System (K242452) | Paragon 28, Inc. | 2024-11-01 |
| Phantom Fibula Nail System (K234128) | Paragon 28, Inc. | 2024-08-22 |
| Grappler Interference Screw System (K241864) | Paragon 28, Inc. | 2024-07-25 |
| APEX 3D Total Ankle Replacement System (K240259) | Paragon 28, Inc. | 2024-06-24 |
| Baby Gorilla/Gorilla Plating System; Monster Screw System (K241262) | Paragon 28, Inc. | 2024-06-05 |
| Grappler Suture Anchor R3FLEX IOL System (K240594) | Paragon 28, Inc. | 2024-03-26 |
| MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (K231231) | Paragon 28, Inc. | 2023-10-12 |
| Monkey RingsTM External Fixation System (K232838) | Paragon 28, Inc. | 2023-10-12 |
| TITAN 3-D Wedge System (K231496) | Paragon 28, Inc. | 2023-08-22 |
| Grappler Suture Anchor System (K231867) | Paragon 28, Inc. | 2023-08-21 |
| JAWS Nitinol Staple System (K230550) | Paragon 28, Inc. | 2023-05-11 |
| Grappler Suture Anchor R3FLEX IOL System (K223589) | Paragon 28, Inc. | 2023-03-03 |
| JAWS Nitinol Staple System (K223056) | Paragon 28, Inc. | 2023-02-16 |
| Phantom Metatarsal Shortening System (K223184) | Paragon 28, Inc. | 2022-12-16 |
| MAVEN™ Patient-Specific Instrumentation (K223227) | Paragon 28, Inc. | 2022-11-17 |
| Grappler Suture Anchor System (K222091) | Paragon 28, Inc. | 2022-09-14 |
| Baby Gorilla®/Gorilla® Plating System (K222194) | Paragon 28, Inc. | 2022-08-19 |
| Baby Gorilla/Gorilla Plating System (K221465) | Paragon 28, Inc. | 2022-06-17 |
| R3ACT Stabilization System (K211770) | Paragon 28, Inc. | 2021-12-25 |
| Paragon 28 External Ring Fixation System (K212895) | Paragon 28, Inc. | 2021-11-08 |
| Paratrooper Plantar Plate Repair System (K211322) | Paragon 28, Inc. | 2021-08-30 |
| Grappler Suture Anchor System (K211002) | Paragon 28, Inc. | 2021-07-07 |
| Phantom Hindfoot TTC/TC Nail System (K210869) | Paragon 28, Inc. | 2021-06-28 |
| Apex 3D Total Ankle Replacement System (K210390) | Paragon 28, Inc. | 2021-03-06 |
| TenoTac Soft Tissue Fixation System (K203385) | Paragon 28, Inc. | 2021-02-11 |
| Maven Patient-Specific Instrumentation (K202019) | Paragon 28, Inc. | 2021-01-14 |
| Baby Gorilla/Gorilla Plating System (K203511) | Paragon 28, Inc. | 2020-12-29 |
| Monster Screw System (K203011) | Paragon 28, Inc. | 2020-11-13 |
| APEX 3D Total Ankle Replacement System (K202373) | Paragon 28, Inc. | 2020-11-13 |
| Phantom® Hindfoot TTC/TC Nail System (K201227) | Paragon 28, Inc. | 2020-07-17 |
| Paragon 28 APEX 3D Total Ankle Replacement System (K192994) | Paragon 28, Inc. | 2020-07-10 |
| TTC Phantom® Intramedullary Nail System (K192163) | Paragon 28, Inc. | 2020-01-31 |
| Paratrooper Plantar Plate Repair System (K191227) | Paragon 28, Inc. | 2020-01-24 |
| TTC Phantom Intramedullary Nail System (K191782) | Paragon 28, Inc. | 2019-09-06 |
| Baby Gorilla/Gorilla Plating System (K190365) | Paragon 28, Inc. | 2019-04-12 |
| Monster® Screw System (K190586) | Paragon 28, Inc. | 2019-04-03 |
| Tenodesis Screw System (K183690) | Paragon 28, Inc. | 2019-03-01 |
| HammerToe Compression System (K183228) | Paragon 28, Inc. | 2019-01-25 |
| TenoTac Soft Tissue Fixation System (K182898) | Paragon 28, Inc. | 2019-01-14 |
| Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (K182307) | Paragon 28, Inc. | 2019-01-14 |
| SILVERBACK Gorilla Plating System (K182148) | Paragon 28, Inc. | 2018-09-07 |
| Phantom Small Bone Intramedullary Nail System (K170693) | Paragon 28, Inc. | 2017-06-19 |