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Device Explorer · FDA GUDID · GMDN 48067

Knee arthroplasty wedge

An implantable device designed to augment the implantation of a knee femur or tibia prosthesis by serving as a space-filler adjacent to the prosthesis, typically to replace lost bone and increase bone contact area and aid stability. It is typically made of met

US‑registered devices4,393in commercial distribution
Companies24labelers on GUDID
Single‑use97%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Zimmer, Inc.61614%
Waldemar Link Gmbh & Co. Kg52812%
Biomet Orthopedics, Llc45910%
Microport Orthopedics Inc.3779%
Smith & Nephew, Inc.3147%
Howmedica Osteonics Corp.2887%
Medacta International Sa2806%
Depuy (Ireland)2436%

Top labelers

CompanyDevicesShare
Zimmer, Inc.61614%
Waldemar Link Gmbh & Co. Kg52812%
Biomet Orthopedics, Llc45910%
Microport Orthopedics Inc.3779%
Smith & Nephew, Inc.3147%
Howmedica Osteonics Corp.2887%
Medacta International Sa2806%
Depuy (Ireland)2436%
Ortho Development Corporation2075%
Exactech, Inc.1684%
Zimmer Trabecular Metal Technology Inc.1533%
Corin Ltd1283%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TRIATHLONTriathlonKinemaxDuraconScorpioHLS Noetos RevisionUnity Total Knee SystemAGC REVISION KNEEn/aACS®Endo-Model Modular Knee Prosthesis SystemEndo-Model SL Knee Prosthesis SystemMegasystem CEndo-Model Standard Knee Prosthesis SystemLinkSymphoKneeLINK Endo-Model EVO 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, CEM2,976
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem1,055
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN1,030
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL744
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem406
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal326

GMDN & GCC registration

  • GMDN code 48067 · implantable
  • Single‑use 97% · sterile 100% · 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

Height (Millimeter) · 566Angle (degree) · 42Length (Millimeter) · 23Width (Millimeter) · 11Lumen/Inner Diameter (Millimeter) · 3Outer Diameter (Millimeter) · 3

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

How many knee arthroplasty wedge products are registered in the US?

4,393 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Knee arthroplasty wedge", from 24 companies. The largest labeler is Zimmer, Inc. with 14% 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), 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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