Paragon 28
Englewood, CO, US
PARAGON 28 appears in FDA device records in Englewood, CO. FDA records list 59 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 59FDA records hold 59 510(k) clearances for Paragon 28 between 2014 and 2026. The busiest year on record is 2021, with 8. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 2 |
| 2017 | 4 |
| 2018 | 2 |
| 2019 | 7 |
| 2020 | 7 |
| 2021 | 8 |
| 2022 | 5 |
| 2023 | 7 |
| 2024 | 6 |
| 2025 | 6 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261121 | Megalodon Dynamic Compression System | JDR | Substantially Equivalent | |
| K262047 | Grappler Suture Anchor System | MBI | Substantially Equivalent | |
| K253886 | Grappler Suture Anchor PCFD Tether System | MBI | Substantially Equivalent | |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | HSB | Substantially Equivalent | |
| K253613 | Monkey Rings External Ring Fixation System | KTT | Substantially Equivalent | |
| K252106 | External Fixation Mini Rail System | KTT | Substantially Equivalent | |
| K251862 | External Fixation Bone Distractor | KTT | Substantially Equivalent | |
| K250952 | Baby Gorilla®/Gorilla® Plating System | HRS | Substantially Equivalent | |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | HSB | Substantially Equivalent | |
| K250641 | APEX 3D Total Ankle Replacement System | HSN | Substantially Equivalent | |
| K242452 | Monkey Bars Pin to Bar External Fixation System | KTT | Substantially Equivalent | |
| K234128 | Phantom Fibula Nail System | HSB | Substantially Equivalent | |
| K241864 | Grappler Interference Screw System | MBI | Substantially Equivalent | |
| K240259 | APEX 3D Total Ankle Replacement System | HSN | Substantially Equivalent | |
| K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | HRS | Substantially Equivalent | |
| K240594 | Grappler Suture Anchor R3FLEX IOL System | MBI | Substantially Equivalent | |
| K232838 | Monkey RingsTM External Fixation System | KTT | Substantially Equivalent | |
| K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices | HWC | Substantially Equivalent | |
| K231496 | TITAN 3-D Wedge System | PLF | Substantially Equivalent | |
| K231867 | Grappler Suture Anchor System | MBI | Substantially Equivalent | |
| K230550 | JAWS Nitinol Staple System | JDR | Substantially Equivalent | |
| K223589 | Grappler Suture Anchor R3FLEX IOL System | MBI | Substantially Equivalent | |
| K223056 | JAWS Nitinol Staple System | JDR | Substantially Equivalent | |
| K223184 | Phantom Metatarsal Shortening System | HWC | Substantially Equivalent | |
| K223227 | MAVEN™ Patient-Specific Instrumentation | HSN | Substantially Equivalent | |
| K222091 | Grappler Suture Anchor System | MBI | Substantially Equivalent | |
| K222194 | Baby Gorilla®/Gorilla® Plating System | HRS | Substantially Equivalent | |
| K221465 | Baby Gorilla/Gorilla Plating System | HRS | Substantially Equivalent | |
| K211770 | R3ACT Stabilization System | HWC | Substantially Equivalent | |
| K212895 | Paragon 28 External Ring Fixation System | KTT | Substantially Equivalent | |
| K211322 | Paratrooper Plantar Plate Repair System | MBI | Substantially Equivalent | |
| K211002 | Grappler Suture Anchor System | MBI | Substantially Equivalent | |
| K210869 | Phantom Hindfoot TTC/TC Nail System | HSB | Substantially Equivalent | |
| K210390 | Apex 3D Total Ankle Replacement System | HSN | Substantially Equivalent | |
| K203385 | TenoTac Soft Tissue Fixation System | MBI | Substantially Equivalent | |
| K202019 | Maven Patient-Specific Instrumentation | HSN | Substantially Equivalent | |
| K203511 | Baby Gorilla/Gorilla Plating System | HRS | Substantially Equivalent | |
| K203011 | Monster Screw System | HWC | Substantially Equivalent | |
| K202373 | APEX 3D Total Ankle Replacement System | HSN | Substantially Equivalent | |
| K201227 | Phantom® Hindfoot TTC/TC Nail System | HSB | Substantially Equivalent | |
| K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | HSN | Substantially Equivalent | |
| K192163 | TTC Phantom® Intramedullary Nail System | HSB | Substantially Equivalent | |
| K191227 | Paratrooper Plantar Plate Repair System | MBI | Substantially Equivalent | |
| K191782 | TTC Phantom Intramedullary Nail System | HSB | Substantially Equivalent | |
| K190365 | Baby Gorilla/Gorilla Plating System | HRS | Substantially Equivalent | |
| K190586 | Monster® Screw System | HWC | Substantially Equivalent | |
| K183690 | Tenodesis Screw System | MBI | Substantially Equivalent | |
| K183228 | HammerToe Compression System | HTY | Substantially Equivalent | |
| K182898 | TenoTac Soft Tissue Fixation System | MBI | Substantially Equivalent | |
| K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System | HSB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008650117 | 3008650117 | PARAGON 28 | 14445 Grasslands Dr., Englewood, CO 80112 US | 2026 | and 41 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OYKAnkle Arthroplasty Implantation System
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component
- HXWBender
- HTWBit, Drill
- GFABlade, Saw, General & Plastic Surgery, Surgical
- PLFBone Wedge
- GFFBur, Surgical, General & Plastic Surgery
- FZOChisel, Surgical, Manual
- HWWCountersink
- HTFCurette
- HWBExtractor
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- MQVFiller, Bone Void, Calcium Compound
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- KIKHook, Bone
- HWAImpactor
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- KDDKit, Surgical Instrument, Disposable
- GAANeedle, Aspiration And Injection, Disposable
- PBFOrthopaedic Surgical Planning And Instrument Guides
- LXHOrthopedic Manual Surgical Instrument
- HWMOsteotome
- HXIPasser, Wire, Orthopedic
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- QNNProsthesis, Total Talus Replacement, Metal
- HTRRasp
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HTXRongeur
- HABSaw, Powered, And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- FPASet, Administration, Intravascular
- JDRStaple, Fixation, Bone
- GAHStylet, Surgical, General & Plastic Surgery
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- FMFSyringe, Piston
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HWKTrephine
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2972-2026 | Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. | Class III | Open, Classified | |
| Z-2971-2026 | Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. | Class III | Open, Classified | |
| 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. | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. | Class II | Open, Classified | |
| 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 not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted. | Class II | Open, Classified | |
| Z-1256-2024 | Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R | Medical devices distributed, prior to sterilization | Class II | Open, Classified | |
| Z-1255-2024 | Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L | Medical devices distributed, prior to sterilization | Class II | Open, Classified | |
| Z-1254-2024 | Phantom TTC Nail, 10.0 X 200mm, Right | Medical devices distributed, prior to sterilization | Class II | Open, Classified | |
| 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 | Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. | Class II | Open, Classified | |
| Z-1468-2022 | HammerTube Implant, 2.75mm, 10 Cannulated (Sterile) | Due to Titanium plasma coating not present implant. | Class II | Open, Classified | |
| 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 | Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. | Class II | Open, Classified | |
| 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 cannulation beneath. | Class II | Terminated | |
| Z-0662-2020 | P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only | It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery. | Class II | Terminated | |
| Z-2261-2018 | P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments. | Missing drill guide as stated in the package. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain