Consulting Wallah › Device Explorer › Orthopaedic implants › Uncoated knee tibia/insert prosthesis
Device Explorer · FDA GUDID · GMDN 33666

Uncoated knee tibia/insert prosthesis

A sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision). It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is n

US‑registered devices1,588in commercial distribution
Companies6labelers on GUDID
Single‑use99%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Orthopedics, Llc58237%
Corentec Co., Ltd53334%
Arthrex, Inc.40926%
Waldemar Link Gmbh & Co. Kg423%
Onkos Surgical, Inc.201%
Conformis, Inc.20%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc58237%
Corentec Co., Ltd53334%
Arthrex, Inc.40926%
Waldemar Link Gmbh & Co. Kg423%
Onkos Surgical, Inc.201%
Conformis, Inc.20%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Endo-Model SL Knee Prosthesis SystemEndo-Model®-M Rotational Knee ProsthesisEndo-Model Modular Knee Prosthesis SystemLINK Endo-Model EVO Knee SystemVanguard XP® Complete Knee SystemArthrex®Vanguard® Complete Knee SolutionVANGUARD® COMPLETE KNEE SYSTEMVanguard® Complete Knee SystemVanguard Complete Knee SystemVANGUARD COMPLETE KNEE SYSTEMVanguard Knee SystemVANGUARD KNEE SYSTEMAGC KNEE SYSTEMMAXIM VI KNEE SYSTEMELEOS™ Limb Salvage System

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN921
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM592
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem535
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem521
MBVProsthesis, knee, patello/femorotibial, semi-constrained, uh521
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTE398

GMDN & GCC registration

  • GMDN code 33666 · implantable
  • Single‑use 99% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 11

Use these as the dimensions to specify in a tender line.

How many uncoated knee tibia/insert prosthesis products are registered in the US?

1,588 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uncoated knee tibia/insert prosthesis", from 6 companies. The largest labeler is Biomet Orthopedics, Llc with 37% of records.

Which FDA product codes apply?

MBH (PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), OIY (Prosthesis, knee, patellofemorotibial, semi-constrained, cem)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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