ClearanceBrief
Company · US

Paragon 28, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.

61510(k) clearances (7 in 12 months)
13recalls (4 in 12 months)
8recalls that name a 510(k)

Product codes

CodeDeviceRecords
MBIFastener, Fixation, Nondegradable, Soft Tissue14
HSBRod, Fixation, Intramedullary And Accessories12
HRSPlate, Fixation, Bone9
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer8
HWCScrew, Fixation, Bone8
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component6
JDRStaple, Fixation, Bone5
PLFBone Wedge5
HTYPin, Fixation, Smooth4
HTWBit, Drill1
HXIPasser, Wire, Orthopedic1
KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 7, 2026K261120APEX 3D S Diamond Tibia
Paragon 28, Inc.
HSN
Aug 28, 2026K262722Primal K-Wire (P99-193-1410)
Paragon 28, Inc.
HTY
Aug 6, 2026K261121Megalodon Dynamic Compression System
Paragon 28, Inc.
JDR
Aug 3, 2026K262047Grappler Suture Anchor System
Paragon 28, Inc.
MBI
Mar 17, 2026K253886Grappler Suture Anchor PCFD Tether System
Paragon 28, Inc.
MBI
Mar 5, 2026K253591Phantom® Hindfoot TTC/TC Nail System
Paragon 28, Inc.
HSB
Dec 19, 2025K253613Monkey Rings External Ring Fixation System
Paragon 28, Inc.
KTT
Sep 30, 2025K252106External Fixation Mini Rail System
Paragon 28, Inc.
KTT
Aug 11, 2025K251862External Fixation Bone Distractor
Paragon 28, Inc.
KTT
Jul 18, 2025K250952Baby Gorilla®/Gorilla® Plating System
Paragon 28, Inc.
HRS
Jul 14, 2025K251850Phantom® Hindfoot TTC/TC Nail System
Paragon 28, Inc.
HSB
May 1, 2025K250641APEX 3D Total Ankle Replacement System
Paragon 28, Inc.
HSN
Nov 1, 2024K242452Monkey Bars Pin to Bar External Fixation System
Paragon 28, Inc.
KTT
Aug 22, 2024K234128Phantom Fibula Nail System
Paragon 28, Inc.
HSB
Jul 25, 2024K241864Grappler Interference Screw System
Paragon 28, Inc.
MBI
Jun 24, 2024K240259APEX 3D Total Ankle Replacement System
Paragon 28, Inc.
HSN
Jun 5, 2024K241262Baby Gorilla/Gorilla Plating System; Monster Screw System
Paragon 28, Inc.
HRS
Mar 26, 2024K240594Grappler Suture Anchor R3FLEX IOL System
Paragon 28, Inc.
MBI
Oct 12, 2023K232838Monkey RingsTM External Fixation System
Paragon 28, Inc.
KTT
Oct 12, 2023K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
Paragon 28, Inc.
HWC
Aug 22, 2023K231496TITAN 3-D Wedge System
Paragon 28, Inc.
PLF
Aug 21, 2023K231867Grappler Suture Anchor System
Paragon 28, Inc.
MBI
May 11, 2023K230550JAWS Nitinol Staple System
Paragon 28, Inc.
JDR
Mar 3, 2023K223589Grappler Suture Anchor R3FLEX IOL System
Paragon 28, Inc.
MBI
Feb 16, 2023K223056JAWS Nitinol Staple System
Paragon 28, Inc.
JDR
Dec 16, 2022K223184Phantom Metatarsal Shortening System
Paragon 28, Inc.
HWC
Nov 17, 2022K223227MAVEN™ Patient-Specific Instrumentation
Paragon 28, Inc.
HSN
Sep 14, 2022K222091Grappler Suture Anchor System
Paragon 28, Inc.
MBI
Aug 19, 2022K222194Baby Gorilla®/Gorilla® Plating System
Paragon 28, Inc.
HRS
Jun 17, 2022K221465Baby Gorilla/Gorilla Plating System
Paragon 28, Inc.
HRS
Dec 25, 2021K211770R3ACT Stabilization System
Paragon 28, Inc.
HWC
Nov 8, 2021K212895Paragon 28 External Ring Fixation System
Paragon 28, Inc.
KTT
Aug 30, 2021K211322Paratrooper Plantar Plate Repair System
Paragon 28, Inc.
MBI
Jul 7, 2021K211002Grappler Suture Anchor System
Paragon 28, Inc.
MBI
Jun 28, 2021K210869Phantom Hindfoot TTC/TC Nail System
Paragon 28, Inc.
HSB
Mar 6, 2021K210390Apex 3D Total Ankle Replacement System
Paragon 28, Inc.
HSN
Feb 11, 2021K203385TenoTac Soft Tissue Fixation System
Paragon 28, Inc.
MBI
Jan 14, 2021K202019Maven Patient-Specific Instrumentation
Paragon 28, Inc.
HSN
Dec 29, 2020K203511Baby Gorilla/Gorilla Plating System
Paragon 28, Inc.
HRS
Nov 13, 2020K203011Monster Screw System
Paragon 28, Inc.
HWC
Nov 13, 2020K202373APEX 3D Total Ankle Replacement System
Paragon 28, Inc.
HSN
Jul 17, 2020K201227Phantom® Hindfoot TTC/TC Nail System
Paragon 28, Inc.
HSB
Jul 10, 2020K192994Paragon 28 APEX 3D Total Ankle Replacement System
Paragon 28, Inc.
HSN
Jan 31, 2020K192163TTC Phantom® Intramedullary Nail System
Paragon 28, Inc.
HSB
Jan 24, 2020K191227Paratrooper Plantar Plate Repair System
Paragon 28, Inc.
MBI
Sep 6, 2019K191782TTC Phantom Intramedullary Nail System
Paragon 28, Inc.
HSB
Apr 12, 2019K190365Baby Gorilla/Gorilla Plating System
Paragon 28, Inc.
HRS
Apr 3, 2019K190586Monster® Screw System
Paragon 28, Inc.
HWC
Mar 1, 2019K183690Tenodesis Screw System
Paragon 28, Inc.
MBI
Jan 25, 2019K183228HammerToe Compression System
Paragon 28, Inc.
HTY

Newest 50 of 61.

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 14, 2026Paragon 28, Inc.
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Open, Classified		 PLFNone listed
Aug 14, 2026Paragon 28, Inc.
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Open, Classified		 PLFNone listed
Jul 17, 2026Paragon 28, Inc.
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.
Open, Classified		 HXINone listed
Dec 2, 2025Paragon 28, Inc.
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Open, Classified		 HSBK234128
Mar 5, 2024Paragon 28, Inc.
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Open, Classified		 HSBK210869
Mar 5, 2024Paragon 28, Inc.
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Open, Classified		 HSBK210869
Mar 5, 2024Paragon 28, Inc.
Phantom TTC Nail, 10.0 X 200mm, Right
Open, Classified		 HSBK210869
Sep 22, 2022Paragon 28, Inc.
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Open, Classified		 MBIK211002
May 26, 2022Paragon 28, Inc.
HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
Open, Classified		 HTYK171715
May 18, 2022Paragon 28, Inc.
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Open, Classified		 HRSNone listed
Jul 30, 2021Paragon 28, Inc.
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Terminated		 HTWNone listed
Dec 10, 2019Paragon 28, Inc.
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
Terminated		 PLFK162241
Dec 19, 2017Paragon 28, Inc.
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.
Terminated		 JDRK170923
Get alerts for these product codes