Device Explorer · FDA GUDID · GMDN 46585

Tibial insert

An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.

US‑registered devices22,442in commercial distribution
Companies34labelers on GUDID
Single‑use98%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Zimmer, Inc.3,28115%
Howmedica Osteonics Corp.2,0619%
Signature Orthopaedics Pty Ltd1,8948%
Exactech, Inc.1,5107%
Depuy (Ireland)1,3586%
Microport Orthopedics Inc.1,3466%
Biomet Orthopedics, Llc1,2606%
Globus Medical, Inc.1,0245%

Top labelers

CompanyDevicesShare
Zimmer, Inc.3,28115%
Howmedica Osteonics Corp.2,0619%
Signature Orthopaedics Pty Ltd1,8948%
Exactech, Inc.1,5107%
Depuy (Ireland)1,3586%
Microport Orthopedics Inc.1,3466%
Biomet Orthopedics, Llc1,2606%
Globus Medical, Inc.1,0245%
Ortho Development Corporation9434%
Corentec Co., Ltd7884%
Conformis, Inc.7803%
Limacorporate Spa7803%

Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TriathlonTriatlhlonKINEMAX IIITRIATHLONKinemaxDuraconScorpioGMRSKinematicSeries 7000Series IISeries IP.C.A.TC-PLUSTC_PLUSUnity Total 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
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM11,735
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem8,275
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN4,190
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem3,509
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem2,262
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 1,226

GMDN & GCC registration

  • GMDN code 46585 · implantable
  • Single‑use 98% · sterile 100% · Rx‑only 98% · 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) · 5,954Width (Millimeter) · 393Length (Millimeter) · 70

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

How many tibial insert products are registered in the US?

22,442 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tibial insert", from 34 companies. The largest labeler is Zimmer, Inc. with 15% 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), OIY (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.

How do I get quotes?

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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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