Data / Medical devices / United States / Paragon 28
Paragon 28: FDA-registered device maker in Englewood, CO, United States, 60 510(k) clearances
Paragon 28 is registered with the FDA (registration 3008650117) in Englewood, CO, United States. It lists 51 device types. The FDA files 60 510(k) clearances under its listings, the newest dated October 7, 2026. 10 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008650117
- Address
- 14445 Grasslands Dr., Englewood, CO, United States, 80112
- Owner or operator
- Paragon 28 (10033376)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 28, 2013
- Registered through
- 2027
- Brand names listed
- APEX 3D S Total Ankle Replacement System, APEX 3D Total Ankle Replacement System, APEX 3D Total Ankle Replacement System, APEX 3D S Diamond Tibia, Actuation Driver, Additive Orthopaedics Bunion System, Additive Orthopaedics Hammertoe Correction System, Additive Orthopaedics Locking Lattice Plate, Additive Orthopaedics Locking Lattice Screw and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ankle Arthroplasty Implantation System | OYK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bone Wedge | PLF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bur, Surgical, General & Plastic Surgery | GFF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Countersink | HWW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Repackager or relabeler | accessdata.fda.gov |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Osteotome | HWM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Total Talus Replacement, Metal | QNN | f | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Saw, Powered, And Accessories | HAB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Trephine | HWK | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 7, 2026 | K261120 | APEX 3D S Diamond Tibia | HSN | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| August 6, 2026 | K261121 | Megalodon Dynamic Compression System | JDR | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| August 3, 2026 | K262047 | Grappler Suture Anchor System | MBI | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| March 17, 2026 | K253886 | Grappler Suture Anchor PCFD Tether System | MBI | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| March 5, 2026 | K253591 | Phantom® Hindfoot TTC/TC Nail System | HSB | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| December 19, 2025 | K253613 | Monkey Rings External Ring Fixation System | KTT | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| September 30, 2025 | K252106 | External Fixation Mini Rail System | KTT | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| August 11, 2025 | K251862 | External Fixation Bone Distractor | KTT | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| July 18, 2025 | K250952 | Baby Gorilla®/Gorilla® Plating System | HRS | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| July 14, 2025 | K251850 | Phantom® Hindfoot TTC/TC Nail System | HSB | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| May 1, 2025 | K250641 | APEX 3D Total Ankle Replacement System | HSN | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| November 1, 2024 | K242452 | Monkey Bars Pin to Bar External Fixation System | KTT | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| August 22, 2024 | K234128 | Phantom Fibula Nail System | HSB | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| June 24, 2024 | K240259 | APEX 3D Total Ankle Replacement System | HSN | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| June 5, 2024 | K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | HRS | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| March 26, 2024 | K240594 | Grappler Suture Anchor R3FLEX IOL System | MBI | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| October 12, 2023 | K232838 | Monkey RingsTM External Fixation System | KTT | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| October 12, 2023 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices | HWC | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| August 21, 2023 | K231867 | Grappler Suture Anchor System | MBI | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| May 11, 2023 | K230550 | JAWS Nitinol Staple System | JDR | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| February 16, 2023 | K223056 | JAWS Nitinol Staple System | JDR | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| December 16, 2022 | K223184 | Phantom Metatarsal Shortening System | HWC | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| September 14, 2022 | K222091 | Grappler Suture Anchor System | MBI | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| August 19, 2022 | K222194 | Baby Gorilla®/Gorilla® Plating System | HRS | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| June 28, 2022 | K211076 | Patient Specific Marking Guides | PBF | Substantially Equivalent | Additive Orthopaedics, LLC | accessdata.fda.gov |
| June 17, 2022 | K221465 | Baby Gorilla/Gorilla Plating System | HRS | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| December 25, 2021 | K211770 | R3ACT Stabilization System | HWC | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| November 8, 2021 | K212895 | Paragon 28 External Ring Fixation System | KTT | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| August 30, 2021 | K211322 | Paratrooper Plantar Plate Repair System | MBI | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| July 7, 2021 | K211002 | Grappler Suture Anchor System | MBI | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| June 28, 2021 | K210869 | Phantom Hindfoot TTC/TC Nail System | HSB | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| May 5, 2021 | K211112 | OIC External Fixation System | KTT | Substantially Equivalent | Orthopaedic Implant Company | accessdata.fda.gov |
| March 6, 2021 | K210390 | Apex 3D Total Ankle Replacement System | HSN | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| February 11, 2021 | K203385 | TenoTac Soft Tissue Fixation System | MBI | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| January 14, 2021 | K202019 | Maven Patient-Specific Instrumentation | HSN | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| December 29, 2020 | K203511 | Baby Gorilla/Gorilla Plating System | HRS | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| November 13, 2020 | K203011 | Monster Screw System | HWC | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| July 22, 2020 | K200513 | DAC Dynamic Active Compression Plate | HRS | Substantially Equivalent | Pioneer Surgical Technology, Inc., Dba Rti Surgical | accessdata.fda.gov |
| July 17, 2020 | K201227 | Phantom® Hindfoot TTC/TC Nail System | HSB | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| July 10, 2020 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | HSN | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| February 18, 2020 | K192674 | Mixing and Delivery System | FMF | Substantially Equivalent | Bone Solutions, Inc. | accessdata.fda.gov |
| January 24, 2020 | K191227 | Paratrooper Plantar Plate Repair System | MBI | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| April 12, 2019 | K190365 | Baby Gorilla/Gorilla Plating System | HRS | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| April 3, 2019 | K190586 | Monster® Screw System | HWC | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| March 1, 2019 | K183690 | Tenodesis Screw System | MBI | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| January 14, 2019 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System | HSB | Substantially Equivalent | Paragon 28, Inc. | accessdata.fda.gov |
| January 10, 2019 | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | HRS | Substantially Equivalent | Additive Orthopaedics | accessdata.fda.gov |
| May 16, 2018 | K180239 | Additive Orthopaedics Patient Specific 3D Printed Bone Segments | HRS | Substantially Equivalent | Additive Orthopaedics, LLC | accessdata.fda.gov |
| March 5, 2018 | K171715 | HammerTube System | HTY | Substantially Equivalent | Paragon 28 | accessdata.fda.gov |
| July 24, 2017 | K170923 | JAWS(TM) Nitinol Staple System | JDR | Substantially Equivalent | Paragon 28 | accessdata.fda.gov |
| June 20, 2017 | K163593 | Additive Orthopaedics Bunion System | HRS | Substantially Equivalent | Additive Orthopaedics, LLC | accessdata.fda.gov |
| April 13, 2017 | K170214 | Additive Orthopaedics Locking Lattice Plate | HRS | Substantially Equivalent | Additive Orthopaedics, LLC | accessdata.fda.gov |
| April 3, 2017 | K162241 | TITAN 3-D Wedge System | PLF | Substantially Equivalent | Paragon 28 | accessdata.fda.gov |
| June 1, 2016 | K160264 | Additive Orthopaedics Hammertoe Correction System | HTY | Substantially Equivalent | Additive Orthopaedics, LLC | accessdata.fda.gov |
| December 21, 2015 | K153378 | Monster BITE Screw System | HWC | Substantially Equivalent | Paragon 28 | accessdata.fda.gov |
| August 18, 2015 | K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty | MQV | Substantially Equivalent | Bacterin International, Inc. | accessdata.fda.gov |
| July 15, 2015 | K151418 | Monster Screw System | HWC | Substantially Equivalent | Paragon 28 | accessdata.fda.gov |
| May 31, 2013 | K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | MBP | Substantially Equivalent | Bacterin International, Inc. | accessdata.fda.gov |
| May 21, 2009 | K071004 | OSTEOCRETE BONE VOID FILLER | MQV | Substantially Equivalent | Bone Solutions, Inc. | accessdata.fda.gov |
| June 29, 1998 | K981386 | MANAN BLUNT NEEDLE | FPA | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 10, 2026 | 99504 | Class III | Ongoing | 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. | accessdata.fda.gov |
| June 17, 2026 | 99276 | Class II | Ongoing | 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. | accessdata.fda.gov |
| October 13, 2025 | 97891 | Class II | Ongoing | 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. | accessdata.fda.gov |
| December 21, 2023 | 93900 | Class II | Ongoing | Phantom TTC Nail, 10.0 X 200mm, Right | Medical devices distributed, prior to sterilization | accessdata.fda.gov |
| July 13, 2022 | 90753 | Class II | Ongoing | 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. | accessdata.fda.gov |
| May 26, 2022 | 90436 | Class II | Ongoing | HammerTube Implant, 2.75mm, 10 Cannulated (Sterile) | Due to Titanium plasma coating not present implant. | accessdata.fda.gov |
| May 18, 2022 | 90478 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 30, 2021 | 88553 | Class II | Terminated | 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. | accessdata.fda.gov |
| September 28, 2018 | 84234 | Class II | Terminated | 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. | accessdata.fda.gov |
| December 19, 2017 | 80181 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Stylet, Surgical, General & Plastic Surgery
Updated October 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.