Consulting Wallah › Device Explorer › Orthopaedic implants › Knee tibia stem prosthesis
Device Explorer · FDA GUDID · GMDN 64152

Knee tibia stem prosthesis

An implantable uncoated shaft-like device intended to be attached to the tibial baseplate of a modular knee tibia prosthesis to provide anchorage within the tibia. It has a threaded proximal end and is shaped to provide a tight fit with the internal tibial cor

US‑registered devices221in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription96%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Waldemar Link Gmbh & Co. Kg20492%
Implanet94%
Total Joint Orthopedics, Inc.63%
Ortho Development Corporation10%
Medacta International Sa10%

Top labelers

CompanyDevicesShare
Waldemar Link Gmbh & Co. Kg20492%
Implanet94%
Total Joint Orthopedics, Inc.63%
Ortho Development Corporation10%
Medacta International Sa10%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LinkSymphoKneeMADISONBalanced Knee Revision SystemKlassic Knee Tibial Stem Extension, 150mmKlassic Knee Tibial Stem Extension, 125mmKlassic Knee Tibial Stem Extension, 100mmKlassic Knee Tibial Stem Extension, 75mmKlassic Knee Tibial Stem Extension, 50mmKlassic Knee Tibial Stem Extension, 25mmGMK Extension

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, CEM211
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M143
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL143
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 143
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem10
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal1

GMDN & GCC registration

  • GMDN code 64152 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 96% · 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 knee tibia stem prosthesis products are registered in the US?

221 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Knee tibia stem prosthesis", from 5 companies. The largest labeler is Waldemar Link Gmbh & Co. Kg with 92% of records.

Which FDA product codes apply?

JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), HSX (PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M), KRO (PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL), 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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