Consulting Wallah › Device Explorer › Orthopaedic implants › Uncoated knee tibia prosthesis, polyethylene
Device Explorer · FDA GUDID · GMDN 33580

Uncoated knee tibia prosthesis, polyethylene

An implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made entirely of polyethylene (PE) and is not coated with a

US‑registered devices5,155in commercial distribution
Companies14labelers on GUDID
Single‑use95%of device records
Sterile95%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Maxx Orthopedics, Inc.1,68233%
Smith & Nephew, Inc.1,65732%
Waldemar Link Gmbh & Co. Kg52510%
Medacta International Sa4388%
Signature Orthopaedics Pty Ltd4318%
Depuy (Ireland)1563%
Zimmer, Inc.741%
Howmedica Osteonics Corp.671%

Top labelers

CompanyDevicesShare
Maxx Orthopedics, Inc.1,68233%
Smith & Nephew, Inc.1,65732%
Waldemar Link Gmbh & Co. Kg52510%
Medacta International Sa4388%
Signature Orthopaedics Pty Ltd4318%
Depuy (Ireland)1563%
Zimmer, Inc.741%
Howmedica Osteonics Corp.671%
Total Joint Orthopedics, Inc.601%
Shalby Advanced Technologies, Inc.301%
Exactech, Inc.160%
Biomet Orthopedics, Llc80%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TriathlonMRHTC-PLUSTC-PLUS PrimaryGemini SLLinkSymphoKneeEndo-Model Standard Knee Prosthesis SystemJOURNEYLEGIONGENESIS IIGENESISACCURISPROFIXN/ANANexGen® Legacy®

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, CEM3,305
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem1,842
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M444
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL432
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 382
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un162

GMDN & GCC registration

  • GMDN code 33580 · implantable
  • Single‑use 95% · sterile 95% · 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

Depth (Millimeter) · 330Height (Millimeter) · 116

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

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

5,155 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uncoated knee tibia prosthesis, polyethylene", from 14 companies. The largest labeler is Maxx Orthopedics, Inc. with 33% of records.

Which FDA product codes apply?

JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), HSX (PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M), KRO (PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL)

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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