Consulting Wallah › Device Explorer › Orthopaedic implants › Uncoated unicondylar knee femur prosthesis
Device Explorer · FDA GUDID · GMDN 33369

Uncoated unicondylar knee femur prosthesis

A sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with

US‑registered devices200in commercial distribution
Companies10labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Smith & Nephew, Inc.7336%
Medacta International Sa3718%
Depuy (Ireland)2211%
Corin Ltd178%
Zimmer, Inc.168%
Biomet Orthopedics, Llc158%
Globus Medical, Inc.105%
Implantcast Gmbh42%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.7336%
Medacta International Sa3718%
Depuy (Ireland)2211%
Corin Ltd178%
Zimmer, Inc.168%
Biomet Orthopedics, Llc158%
Globus Medical, Inc.105%
Implantcast Gmbh42%
Waldemar Link Gmbh & Co. Kg42%
Conformis, Inc.21%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HLS Uni EvolutionU-KneeTecUniglide Unicondylar Knee ProsthesisACS® UNI LD femoral component cementedUnicondylar Sled ProsthesisJOURNEYGENESISNASTRIDEZUKPersona®Persona® Partial Knee SystemTI REPICCI II KNEE SYSTEMUnicondylar Knee SystemiUni® Femoral KitSIGMA

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

FDA product codes

CodeNameDevices
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M132
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, M76
NPJPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAI46
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 45
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, 23
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTE10

GMDN & GCC registration

  • GMDN code 33369 · implantable
  • Single‑use 100% · 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

Height (Millimeter) · 2

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

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

200 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uncoated unicondylar knee femur prosthesis", from 10 companies. The largest labeler is Smith & Nephew, Inc. with 36% of records.

Which FDA product codes apply?

HSX (PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M), HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, M), NPJ (PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAI), HRY (PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, )

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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