Consulting Wallah › Device Explorer › Orthopaedic implants › Uncoated knee tibia prosthesis, metallic
Device Explorer · FDA GUDID · GMDN 32832

Uncoated knee tibia prosthesis, metallic

An implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome

US‑registered devices3,349in commercial distribution
Companies30labelers on GUDID
Single‑use98%of device records
Sterile99%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Shalby Advanced Technologies, Inc.1,16735%
Zimmer, Inc.2588%
Biomet Orthopedics, Llc2588%
Microport Orthopedics Inc.2247%
Smith & Nephew, Inc.2187%
Signature Orthopaedics Pty Ltd1725%
Exactech, Inc.1143%
Omni Life Science, Inc.1093%

Top labelers

CompanyDevicesShare
Shalby Advanced Technologies, Inc.1,16735%
Zimmer, Inc.2588%
Biomet Orthopedics, Llc2588%
Microport Orthopedics Inc.2247%
Smith & Nephew, Inc.2187%
Signature Orthopaedics Pty Ltd1725%
Exactech, Inc.1143%
Omni Life Science, Inc.1093%
Depuy (Ireland)973%
Ortho Development Corporation843%
Medacta International Sa702%
Waldemar Link Gmbh & Co. Kg682%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TRIATHLONTriathlonGMRSKinemaxMRHSeries 7000DuraconScorpioHLS KneeTecHLS Noetos RevisionHLS NoetosSAIPHMedial Rotation KneeNuffield Total KneeUnity Total Knee SystemRotaglide+ Modular Knee System with Fixed Menisc

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, CEM2,488
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem740
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN391
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 226
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem212
MBVProsthesis, knee, patello/femorotibial, semi-constrained, uh166

GMDN & GCC registration

  • GMDN code 32832 · implantable
  • Single‑use 98% · sterile 99% · Rx‑only 99% · 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

Width (Millimeter) · 46Height (Millimeter) · 30Length (Millimeter) · 18Outer Diameter (Millimeter) · 4

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

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

3,349 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uncoated knee tibia prosthesis, metallic", from 30 companies. The largest labeler is Shalby Advanced Technologies, Inc. with 35% of records.

Which FDA product codes apply?

JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), MBH (PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN), 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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