Device Desk

Private service · Not FDA

FDA device establishment · Englewood, CO

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-3008650117As of September 30, 2026

PARAGON 28

Registration 3008650117FEI 3008650117Englewood, CO

Owner/operator: Paragon 28

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
131
Added, last 12 months
24

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 131

CodeDeviceClassRegulationPremarket
OYKMAVEN PSIAnkle Arthroplasty Implantation SystemClass 221 CFR 888.3110K202019
KTTMonkey Rings External Fixation SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K232838
KTTMonkey Bars™ Pin to Bar External Fixation SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K242452
KTTMonkey Rings External Ring Fixation SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Feb 5, 2026Class 221 CFR 888.3030K253613
KTTMonkey Bars Pin to Bar External Fixation SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K211112
KTTSpider Monkey Bone Transport SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Jan 29, 2026Class 221 CFR 888.3030K251862
KTTThe Brachiator Mini External Fixation SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Dec 11, 2025Class 221 CFR 888.3030K252106
KTTMonkey Rings External Fixation SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K212895
KTWPhantom Small Bone Intramedullary Nail SystemAppliance, Fixation, Nail/Blade/Plate Combination, Single ComponentClass 221 CFR 888.3030K182307
KTWAPEX 3D Total Ankle Replacement SystemAppliance, Fixation, Nail/Blade/Plate Combination, Single ComponentAdded Nov 18, 2025Class 221 CFR 888.3030K231231
PLFTitan 3-D Wedge SystemBone WedgeClass 221 CFR 888.3030K162241
MBIGrappler Suture Anchor SystemFastener, Fixation, Nondegradable, Soft TissueClass 221 CFR 888.3040K211002

and 119 more on your full dossier

What changed

  • Feb 5, 2026Listing added: KTT — Monkey Rings External Ring Fixation System (K253613)
  • Jan 29, 2026Listing added: KTT — Spider Monkey Bone Transport System (K251862)
  • Dec 11, 2025Listing added: KTT — The Brachiator Mini External Fixation System (K252106)
  • Nov 18, 2025Listing added: KTW — APEX 3D Total Ankle Replacement System (K231231)
  • Aug 27, 2026Listing added: MBI — Grappler Suture Anchor System (K262047)
  • Apr 22, 2026Listing added: MBI — axIOLink PCFD Tether System (K253886)
  • May 12, 2026Listing added: MQV — BEAST Injectable Putty (K130498)
  • May 12, 2026Listing added: MBP — BEAST Injectable Putty (K130498)
  • Nov 18, 2025Listing added: HTY — APEX 3D Total Ankle Replacement System (K231231)
  • Nov 18, 2025Listing added: HRS — APEX 3D Total Ankle Replacement System (K231231)
  • Jul 13, 2026Listing added: HRS — DAC Dynamic Active Compression Plate (K200513)
  • Nov 14, 2025Listing added: HSN — APEX 3D Total Ankle Replacement System (K250641)
  • Apr 10, 2026Listing added: HSN — Paragon 28 Custom Made Devices
  • Mar 9, 2026Listing added: HSB — Phantom® Hindfoot TTC/TC Nail System (K253591)
  • Nov 18, 2025Listing added: HSB — APEX 3D Total Ankle Replacement System (K231231)
  • Jul 13, 2026Listing added: HWC — DAC Dynamic Active Compression Plate (K200513)
  • Nov 18, 2025Listing added: HWC — APEX 3D Total Ankle Replacement System (K231231)
  • Mar 9, 2026Listing added: HWC — Phantom® Hindfoot TTC/TC Nail System (K253591)
  • Nov 17, 2025Listing added: FPA — Blunt Needle (K981386)
  • Aug 27, 2026Listing added: JDR — JAWS Nitinol Staple System (K223056)
  • Aug 27, 2026Listing added: JDR — Megalodon Dynamic Compression System (K261121)
  • Nov 18, 2025Listing added: HTN — APEX 3D Total Ankle Replacement System (K231231)
  • Jan 21, 2026Listing added: GFF — Precision MIS Bunion System
  • Jul 7, 2026Listing added: KDD — Primal OCD
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

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Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

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Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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