Consulting Wallah › Device Explorer › Orthopaedic implants › Uncoated unicondylar knee tibia prosthesis, metall
Device Explorer · FDA GUDID · GMDN 48068

Uncoated unicondylar knee tibia prosthesis, metallic

A sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial 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 a

US‑registered devices198in commercial distribution
Companies8labelers 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.8643%
Medacta International Sa4925%
Implantcast Gmbh147%
Biomet Orthopedics, Llc147%
Zimmer, Inc.126%
Depuy (Ireland)126%
Waldemar Link Gmbh & Co. Kg105%
Conformis, Inc.11%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.8643%
Medacta International Sa4925%
Implantcast Gmbh147%
Biomet Orthopedics, Llc147%
Zimmer, Inc.126%
Depuy (Ireland)126%
Waldemar Link Gmbh & Co. Kg105%
Conformis, Inc.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Uni FB tibial component LL/RMUni FB tibial component LM/RLLINK Endo-Model EVO Knee SystemUnicondylar Sled ProsthesisGENESISNAJOURNEYSTRIDEZUKPersona® Partial Knee SystemiUni® Tibial KitSIGMAMOTO Lateral Partial Knee SystemMOTO Partial Knee System - MedialGMK Uni

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, M112
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, M101
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 34
NPJPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAI12
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, 8
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL1

GMDN & GCC registration

  • GMDN code 48068 · 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

No structured size data on the register.

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

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

198 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uncoated unicondylar knee tibia prosthesis, metallic", from 8 companies. The largest labeler is Smith & Nephew, Inc. with 43% of records.

Which FDA product codes apply?

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

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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