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Device Explorer · FDA GUDID · GMDN 34199

Polyethylene patella prosthesis

An implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attach

US‑registered devices1,049in commercial distribution
Companies35labelers on GUDID
Single‑use98%of device records
Sterile98%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Smith & Nephew, Inc.12712%
Biomet Orthopedics, Llc12512%
Howmedica Osteonics Corp.10410%
Signature Orthopaedics Pty Ltd949%
Microport Orthopedics Inc.626%
Zimmer, Inc.596%
Depuy (Ireland)474%
Corentec Co., Ltd434%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.12712%
Biomet Orthopedics, Llc12512%
Howmedica Osteonics Corp.10410%
Signature Orthopaedics Pty Ltd949%
Microport Orthopedics Inc.626%
Zimmer, Inc.596%
Depuy (Ireland)474%
Corentec Co., Ltd434%
Shalby Advanced Technologies, Inc.343%
Exactech, Inc.343%
Globus Medical, Inc.303%
Medacta International Sa303%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TriathlonDuraconScorpioAvonKinemaxPatellaTC-PLUS / RT-PLUSHLS NoetosHLS KneeTecSAIPHMedial Rotation KneeUnity Total Knee SystemRotaglide+ Modular Knee System with Fixed MeniscNuffield Total KneeSLK EvoP.C.A.

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, CEM690
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem344
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN228
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 201
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem157
MBVProsthesis, knee, patello/femorotibial, semi-constrained, uh113

GMDN & GCC registration

  • GMDN code 34199 · implantable
  • Single‑use 98% · sterile 98% · 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

Outer Diameter (Millimeter) · 85Length (Millimeter) · 15Width (Millimeter) · 11Height (Millimeter) · 9Depth (Millimeter) · 6

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

How many polyethylene patella prosthesis products are registered in the US?

1,049 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polyethylene patella prosthesis", from 35 companies. The largest labeler is Smith & Nephew, Inc. with 12% 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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