Consulting Wallah › Device Explorer › Orthopaedic implants › Coated knee femur prosthesis
Device Explorer · FDA GUDID · GMDN 33745

Coated knee femur prosthesis

A sterile implantable device designed to replace the femoral condyles (femoral 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

US‑registered devices2,119in commercial distribution
Companies24labelers on GUDID
Single‑use97%of device records
Sterile99%labelled sterile
Prescription97%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Zimmer, Inc.44521%
Medacta International Sa26613%
Signature Orthopaedics Pty Ltd24612%
Biomet Orthopedics, Llc1577%
Waldemar Link Gmbh & Co. Kg1165%
Smith & Nephew, Inc.1085%
Exactech, Inc.1005%
Microport Orthopedics Inc.954%

Top labelers

CompanyDevicesShare
Zimmer, Inc.44521%
Medacta International Sa26613%
Signature Orthopaedics Pty Ltd24612%
Biomet Orthopedics, Llc1577%
Waldemar Link Gmbh & Co. Kg1165%
Smith & Nephew, Inc.1085%
Exactech, Inc.1005%
Microport Orthopedics Inc.954%
Howmedica Osteonics Corp.804%
Corin Ltd754%
Encore Medical, L.P.653%
Maxx Orthopedics, Inc.643%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TRIATHLON GOLDScorpioTriathlonPlasma Coated NTK SystemRotaglide+ Modular Knee System with Fixed MeniscOSS™ Orthopedic Salvage SystemGemini SLLinkSymphoKneeGENESIS IIVanguard XP® Complete Knee SystemPersona® Knee SystemPersona® PPS®Persona® Trabecular Metal®NexGen®Natural-Knee®PERSONA™ 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, CEM1,180
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN933
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem551
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un442
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem403
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 149

GMDN & GCC registration

  • GMDN code 33745 · implantable
  • Single‑use 97% · sterile 99% · Rx‑only 97% · 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

Depth (Millimeter) · 32Length (Millimeter) · 32Width (Millimeter) · 11

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

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

2,119 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coated knee femur prosthesis", from 24 companies. The largest labeler is Zimmer, Inc. with 21% of records.

Which FDA product codes apply?

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

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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