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Device Explorer · FDA GUDID · GMDN 33667

Trabeculated knee tibia/insert prosthesis

A sterile 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 of metal (e.g., tantalum alloy) and has a convo

US‑registered devices203in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Exactech, Inc.13165%
Zimmer Trabecular Metal Technology Inc.7235%

Top labelers

CompanyDevicesShare
Exactech, Inc.13165%
Zimmer Trabecular Metal Technology Inc.7235%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NEXGEN®TRULIANT®Truliant

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN172
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM172
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un31
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem31

GMDN & GCC registration

  • GMDN code 33667 · 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 trabeculated knee tibia/insert prosthesis products are registered in the US?

203 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Trabeculated knee tibia/insert prosthesis", from 2 companies. The largest labeler is Exactech, Inc. with 65% of records.

Which FDA product codes apply?

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

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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