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Device Explorer · FDA GUDID · GMDN 44362

Constrained polyethylene acetabular liner

A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene

US‑registered devices1,330in commercial distribution
Companies25labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Howmedica Osteonics Corp.38129%
Biomet Orthopedics, Llc18814%
Zimmer, Inc.15312%
Novosource, Llc877%
Implants International Ltd806%
Depuy Orthopaedics, Inc.705%
Kyocera Medical Technologies, Inc.665%
Limacorporate Spa544%

Top labelers

CompanyDevicesShare
Howmedica Osteonics Corp.38129%
Biomet Orthopedics, Llc18814%
Zimmer, Inc.15312%
Novosource, Llc877%
Implants International Ltd806%
Depuy Orthopaedics, Inc.705%
Kyocera Medical Technologies, Inc.665%
Limacorporate Spa544%
Smith & Nephew, Inc.413%
Waldemar Link Gmbh & Co. Kg302%
Globus Medical, Inc.262%
Shalby Advanced Technologies, Inc.232%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

System12System 12Series IIPCAOmnifitTridentX3Trinity Acetabular Hip SystemCermet Series IIIRim-FixP.C.A.PE – cup insert 10°implacross® E PE insert 10ºBiMobileVENTO XLPE LinerTREGOR®

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

FDA product codes

CodeNameDevices
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC494
KWZProsthesis, hip, constrained, cemented or uncemented, metal/490
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented341
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce317
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc264
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented214

GMDN & GCC registration

  • GMDN code 44362 · implantable
  • Single‑use 100% · 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

Lumen/Inner Diameter (Millimeter) · 615Outer Diameter (Millimeter) · 228Lumen/Inner Diameter (Centimeter) · 1

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

How many constrained polyethylene acetabular liner products are registered in the US?

1,330 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Constrained polyethylene acetabular liner", from 25 companies. The largest labeler is Howmedica Osteonics Corp. with 29% of records.

Which FDA product codes apply?

LPH (PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC), KWZ (Prosthesis, hip, constrained, cemented or uncemented, metal/), JDI (Prosthesis, hip, semi-constrained, metal/polymer, cemented), LZO (Prosthesis, hip, semi-constrained, metal/ceramic/polymer, ce)

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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