Device Desk

Private service · Not FDA

FDA device establishment · Salt Lake City, UT

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-3008544874As of September 30, 2026

TOTAL JOINT ORTHOPEDICS, INC.

Registration 3008544874FEI 3008544874Salt Lake City, UT

Owner/operator: Total Joint Orthopedics, Inc

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

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
86
Added, last 12 months
2

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 86

CodeDeviceClassRegulationPremarket
MBBKlassic® Infection SpacerBone Cement, AntibioticAdded Sep 11, 2026Class 221 CFR 888.3027K261734
OQGKlassic HD Acetabular Insert with E-Link PolyHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedClass 221 CFR 888.3358K141972
OQGKlassic HD Hooded Acetabular Insert with E-Link PolyHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedClass 221 CFR 888.3358K173104
OQGFemoral Head Adaptor Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedClass 221 CFR 888.3358K213580
OQG22mm BIOLOX delta Ceramic Femoral HeadHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedClass 221 CFR 888.3358K180929
OQGBIOLOX CONTOURA Ceramic Femoral HeadHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedClass 221 CFR 888.3358K191399
OQGPLATFORM® ACETABULAR CUP WITH TI-COAT®Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedClass 221 CFR 888.3358K220483
KWYKlassic BiPolar 22mm Femoral HeadProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedClass 221 CFR 888.3390K143113
LZOAdapters for BIOLOX OPTION Femoral HeadsProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedClass 221 CFR 888.3353K143407
LZOBIOLOX CONTOURA Ceramic Femoral HeadProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedClass 221 CFR 888.3353K191399
LZOPLATFORM® ACETABULAR CUP WITH TI-COAT®Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedClass 221 CFR 888.3353K220483
LZO22mm BIOLOX delta Ceramic Femoral HeadProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedClass 221 CFR 888.3353K180929

and 74 more on your full dossier

What changed

  • Sep 11, 2026Listing added: MBB — Klassic® Infection Spacer (K261734)
  • Sep 11, 2026Listing added: JWH — Klassic® Infection Spacer (K261734)
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

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