Consulting Wallah › Device Explorer › Orthopaedic implants › Uncoated knee femur prosthesis, metallic
Device Explorer · FDA GUDID · GMDN 32831

Uncoated knee femur prosthesis, metallic

An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chro

US‑registered devices4,143in commercial distribution
Companies30labelers on GUDID
Single‑use96%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Zimmer, Inc.52913%
Biomet Orthopedics, Llc46911%
Waldemar Link Gmbh & Co. Kg2917%
Signature Orthopaedics Pty Ltd2707%
Smith & Nephew, Inc.2566%
Howmedica Osteonics Corp.2386%
Microport Orthopedics Inc.2376%
Medacta International Sa2366%

Top labelers

CompanyDevicesShare
Zimmer, Inc.52913%
Biomet Orthopedics, Llc46911%
Waldemar Link Gmbh & Co. Kg2917%
Signature Orthopaedics Pty Ltd2707%
Smith & Nephew, Inc.2566%
Howmedica Osteonics Corp.2386%
Microport Orthopedics Inc.2376%
Medacta International Sa2366%
Ortho Development Corporation1925%
Maxx Orthopedics, Inc.1734%
Depuy (Ireland)1704%
Corentec Co., Ltd1343%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TRIATHLONTriathlonUnixDuraconScorpioHLS NoetosHLS KneeTecHLS Noetos RevisionSAIPHMedial Rotation KneeNuffield Total KneeRotaglide+ Modular Knee System with Fixed MeniscSLK EvoACS®Gemini SLEndo-Model SL Knee Prosthesis System

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, CEM2,715
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem1,513
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN595
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem512
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL337
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 284

GMDN & GCC registration

  • GMDN code 32831 · implantable
  • Single‑use 96% · sterile 100% · Rx‑only 99% · 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) · 38Length (Millimeter) · 16Outer Diameter (Millimeter) · 9

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

How many uncoated knee femur prosthesis, metallic products are registered in the US?

4,143 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uncoated knee femur prosthesis, metallic", from 30 companies. The largest labeler is Zimmer, Inc. with 13% of records.

Which FDA product codes apply?

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