Consulting Wallah › Device Explorer › Orthopaedic implants › Uncoated unicondylar knee tibia prosthesis, polyet
Device Explorer · FDA GUDID · GMDN 48069

Uncoated unicondylar knee tibia prosthesis, polyethylene

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 polyethylene (PE) and is not coated with a material intended

US‑registered devices386in 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.10928%
Mako Surgical Corp.7219%
Zimmer, Inc.4812%
Depuy (Ireland)4812%
Medacta International Sa4812%
Waldemar Link Gmbh & Co. Kg174%
Howmedica Osteonics Corp.164%
Corin Ltd164%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.10928%
Mako Surgical Corp.7219%
Zimmer, Inc.4812%
Depuy (Ireland)4812%
Medacta International Sa4812%
Waldemar Link Gmbh & Co. Kg174%
Howmedica Osteonics Corp.164%
Corin Ltd164%
Osteoremedies, Llc62%
Exactech, Inc.62%

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

Brand names on the register (sample)

UnixHLS Uni EvolutionUnicondylar Sled ProsthesisLINK Endo-Model EVO Knee SystemJOURNEYGENESISNAZUKREMEDY Poly+Plus Tibial SpacerRESTORISOptetrak UnicondylarSIGMAMOTO Lateral Partial Knee System

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, M276
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 136
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTE120
NPJPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAI120
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, M64
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, 56

GMDN & GCC registration

  • GMDN code 48069 · 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) · 72

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

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

386 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, polyethylene", from 10 companies. The largest labeler is Smith & Nephew, Inc. with 28% of records.

Which FDA product codes apply?

HSX (PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M), HRY (PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, ), KRR (PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTE), 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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