Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paragon 28, Inc. — Predicate Candidate Screening
52 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
175 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | 2026-08-06 | 125 | 0 |
| K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | 2026-08-03 | 46 | 0 |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026-03-17 | 103 | 0 |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026-03-05 | 108 | 0 |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | 2025-12-19 | 31 | 0 |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025-09-30 | 89 | 0 |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | 2025-08-11 | 55 | 0 |
| K250952 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2025-07-18 | 112 | 0 |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025-07-14 | 28 | 0 |
| K250641 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2025-05-01 | 58 | 0 |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | 2024-11-01 | 74 | 0 |
| K234128 | Phantom Fibula Nail System | Paragon 28, Inc. | 2024-08-22 | 238 | 1 |
| K241864 | Grappler Interference Screw System | Paragon 28, Inc. | 2024-07-25 | 28 | 0 |
| K240259 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2024-06-24 | 145 | 0 |
| K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28, Inc. | 2024-06-05 | 30 | 0 |
| K240594 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2024-03-26 | 22 | 0 |
| K231231 | MR Safety and Compatibility Testing and Labeling for Paragon | Paragon 28, Inc. | 2023-10-12 | 167 | 0 |
| K232838 | Monkey RingsTM External Fixation System | Paragon 28, Inc. | 2023-10-12 | 28 | 0 |
| K231496 | TITAN 3-D Wedge System | Paragon 28, Inc. | 2023-08-22 | 90 | 0 |
| K231867 | Grappler Suture Anchor System | Paragon 28, Inc. | 2023-08-21 | 56 | 0 |
| K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-05-11 | 72 | 0 |
| K223589 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2023-03-03 | 92 | 0 |
| K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-02-16 | 139 | 0 |
| K223184 | Phantom Metatarsal Shortening System | Paragon 28, Inc. | 2022-12-16 | 65 | 0 |
| K223227 | MAVEN™ Patient-Specific Instrumentation | Paragon 28, Inc. | 2022-11-17 | 30 | 0 |
| K222091 | Grappler Suture Anchor System | Paragon 28, Inc. | 2022-09-14 | 61 | 0 |
| K222194 | Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. | 2022-08-19 | 28 | 0 |
| K221465 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | 2022-06-17 | 29 | 0 |
| K211770 | R3ACT Stabilization System | Paragon 28, Inc. | 2021-12-25 | 200 | 0 |
| K212895 | Paragon 28 External Ring Fixation System | Paragon 28, Inc. | 2021-11-08 | 59 | 0 |
| K211322 | Paratrooper Plantar Plate Repair System | Paragon 28, Inc. | 2021-08-30 | 122 | 0 |
| K211002 | Grappler Suture Anchor System | Paragon 28, Inc. | 2021-07-07 | 96 | 1 |
| K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2021-06-28 | 97 | 3 |
| K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021-03-06 | 25 | 0 |
| K203385 | TenoTac Soft Tissue Fixation System | Paragon 28, Inc. | 2021-02-11 | 85 | 0 |
| K202019 | Maven Patient-Specific Instrumentation | Paragon 28, Inc. | 2021-01-14 | 177 | 0 |
| K203511 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | 2020-12-29 | 29 | 0 |
| K203011 | Monster Screw System | Paragon 28, Inc. | 2020-11-13 | 43 | 0 |
| K202373 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020-11-13 | 86 | 0 |
| K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020-07-17 | 72 | 0 |
| K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020-07-10 | 259 | 0 |
| K192163 | TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2020-01-31 | 175 | 0 |
| K191227 | Paratrooper Plantar Plate Repair System | Paragon 28, Inc. | 2020-01-24 | 262 | 0 |
| K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019-09-06 | 66 | 0 |
| K190365 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | 2019-04-12 | 56 | 0 |
| K190586 | Monster® Screw System | Paragon 28, Inc. | 2019-04-03 | 28 | 0 |
| K183690 | Tenodesis Screw System | Paragon 28, Inc. | 2019-03-01 | 60 | 0 |
| K183228 | HammerToe Compression System | Paragon 28, Inc. | 2019-01-25 | 66 | 0 |
| K182898 | TenoTac Soft Tissue Fixation System | Paragon 28, Inc. | 2019-01-14 | 90 | 0 |
| K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® | Paragon 28, Inc. | 2019-01-14 | 143 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda