Device Desk

Private service · Not FDA

FDA device establishment · West Chester, PA

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-3008812560As of September 30, 2026

Synthes (USA) Products LLC

Registration 3008812560FEI 3008812560West Chester, PA

Owner/operator: SYNTHES (USA) Products LLC / Medical Device Business Service

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture 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
951
Added, last 12 months
9

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 951

CodeDeviceClassRegulationPremarket
MJOPRODISC-C TOTAL DISC REPLACEMENTProsthesis, Intervertebral DiscClass 3—P070001
MJOPRODISCProsthesis, Intervertebral DiscClass 3—P050010
KTTSYNTHES COMBINATION CLAMP AND DYNAMAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K973017
KTTSYNTHES TITANIUM EXTERNAL FIXATOR CAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K962484
KTTSYNTHES (USA) EXTERNAL FIXATION COMAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K043039
KTTSynthes Reprocessed External FixatiAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K033158
KTTMAXFRAME Multi-Axial Correction System (Aka MAXFRAME)Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K211313
KTTSYNTHES EXTERNAL FIXATION DEVICES,Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K090658
KTTSYNTHES MINI EXTERNAL FIXATORAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K961350
KTTSynthes Distraction Osteogenesis SyAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K051600
KTTSYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP)Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K010766
KTTMAXFRAME AutostrutAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K202810

and 939 more on your full dossier

What changed

  • Jun 16, 2026Listing added: KTT — MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (K254087)
  • May 26, 2026Listing added: GXN — Synthes Patient Specific Implants (K243715)
  • Jun 17, 2026Listing added: HRS — DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System (K254093)
  • Apr 6, 2026Listing added: HRS — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (K260069)
  • May 26, 2026Listing added: HRS — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (K254054)
  • Apr 6, 2026Listing added: HWC — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (K260069)
  • Jun 16, 2026Listing added: OSN — MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (K254087)
  • Apr 6, 2026Listing added: HTD — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (K260069)
  • Apr 6, 2026Listing added: HWT — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (K260069)
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

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

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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