Consulting Wallah › Device Explorer › Orthopaedic implants › Coated knee tibia prosthesis
Device Explorer · FDA GUDID · GMDN 34198

Coated knee tibia 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 c

US‑registered devices985in commercial distribution
Companies21labelers on GUDID
Single‑use94%of device records
Sterile98%labelled sterile
Prescription94%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Orthopedics, Llc16617%
Microport Orthopedics Inc.14615%
Zimmer, Inc.10310%
Smith & Nephew, Inc.828%
Signature Orthopaedics Pty Ltd737%
Encore Medical, L.P.646%
Shalby Advanced Technologies, Inc.636%
Howmedica Osteonics Corp.626%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc16617%
Microport Orthopedics Inc.14615%
Zimmer, Inc.10310%
Smith & Nephew, Inc.828%
Signature Orthopaedics Pty Ltd737%
Encore Medical, L.P.646%
Shalby Advanced Technologies, Inc.636%
Howmedica Osteonics Corp.626%
Medacta International Sa576%
Biopro, Inc.293%
Corin Ltd253%
Waldemar Link Gmbh & Co. Kg242%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TRIATHLONGMRSMRSSeries 7000TriathlonPlasma Coated NTK SystemRotaglide+ Modular Knee System with Fixed MeniscLinkSymphoKneeGemini SLGENESIS IIOSS™ Orthopedic Salvage SystemPersona® The Personalized Knee® OsseoTi®Persona® Natural Tibia® Trabecular Metal®Persona® Natural Tibia™ Trabecular Metal™Natural-Knee®PERSONA™ Natural Tibia™ Trabecular Metal™

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

FDA product codes

CodeNameDevices
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM529
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN283
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un187
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem173
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL121
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem91

GMDN & GCC registration

  • GMDN code 34198 · implantable
  • Single‑use 94% · sterile 98% · Rx‑only 94% · 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

Height (Millimeter) · 22Length (Millimeter) · 7Width (Millimeter) · 5

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

How many coated knee tibia prosthesis products are registered in the US?

985 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coated knee tibia prosthesis", from 21 companies. The largest labeler is Biomet Orthopedics, Llc with 17% of records.

Which FDA product codes apply?

JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), MBH (PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN), MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un), JWH (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.

How do I get quotes?

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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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