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Device Explorer · FDA GUDID · GMDN 43168

Non-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 devices10,419in commercial distribution
Companies38labelers on GUDID
Single‑use99%of device records
Sterile100%labelled sterile
Prescription96%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Zimmer, Inc.2,40923%
Maxx Orthopedics, Inc.1,13511%
Biomet Orthopedics, Llc1,03610%
Signature Orthopaedics Pty Ltd5685%
Howmedica Osteonics Corp.5385%
Smith & Nephew, Inc.5365%
Depuy Orthopaedics, Inc.5365%
Microport Orthopedics Inc.4464%

Top labelers

CompanyDevicesShare
Zimmer, Inc.2,40923%
Maxx Orthopedics, Inc.1,13511%
Biomet Orthopedics, Llc1,03610%
Signature Orthopaedics Pty Ltd5685%
Howmedica Osteonics Corp.5385%
Smith & Nephew, Inc.5365%
Depuy Orthopaedics, Inc.5365%
Microport Orthopedics Inc.4464%
Shalby Advanced Technologies, Inc.3543%
Encore Medical, L.P.3513%
Medacta International Sa2512%
United Orthopedic Corp.2272%

Company = labeler of record on GUDID. 38 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MDM X3 InsertSystem 12Trident X3 InsertRestoration ADM X3 InsertRestoration ADM/MDM X3 InsertRestorationOmnifitTridentPOLARCUPMobiliT CupTrinity Acetabular Hip System with ECiMa LinersC-Fit & DC-Fit Acetabular Cup SystemTrinity Acetabular Hip System with HXLPE LinersTrinity Acetabular Hip SystemUnited Hip SystemX3

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 UNC5,457
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented2,996
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce2,868
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc2,306
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce2,241
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, +1,571

GMDN & GCC registration

  • GMDN code 43168 · implantable
  • Single‑use 99% · sterile 100% · Rx‑only 96% · 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) · 3,234Outer Diameter (Millimeter) · 1,133Angle (degree) · 15Height (Millimeter) · 14Lumen/Inner Diameter (Micrometer) · 2

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

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

10,419 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-constrained polyethylene acetabular liner", from 38 companies. The largest labeler is Zimmer, Inc. with 23% of records.

Which FDA product codes apply?

LPH (PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC), JDI (Prosthesis, hip, semi-constrained, metal/polymer, cemented), LZO (Prosthesis, hip, semi-constrained, metal/ceramic/polymer, ce), LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc)

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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