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Device Explorer · FDA GUDID · GMDN 43167

Acetabular shell

An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation dev

US‑registered devices6,106in commercial distribution
Companies38labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription92%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Orthopedics, Llc88915%
Depuy Orthopaedics, Inc.82814%
Howmedica Osteonics Corp.4497%
Zimmer, Inc.3846%
Ortho Development Corporation3516%
Kyocera Medical Technologies, Inc.2935%
Smith & Nephew, Inc.2835%
Medacta International Sa2755%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc88915%
Depuy Orthopaedics, Inc.82814%
Howmedica Osteonics Corp.4497%
Zimmer, Inc.3846%
Ortho Development Corporation3516%
Kyocera Medical Technologies, Inc.2935%
Smith & Nephew, Inc.2835%
Medacta International Sa2755%
Signature Orthopaedics Pty Ltd2534%
Encore Medical, L.P.2384%
Corin Ltd2284%
Shalby Advanced Technologies, Inc.1823%

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

Brand names on the register (sample)

TRIDENT IITrident IIKerboullTritaniumSecur-FitTridentRestorationPOLARCUPTrinity EVOMobiliT CupCorin Trinity™ PLUS Acetabular ShellTrinity with no TPSTrinity No Hole ShellsTrinity-i Acetabular ShellC-Fit & DC-Fit Acetabular Cup SystemTrinity Acetabular Hip System

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 UNC3,392
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce1,724
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc1,633
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented1,439
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer1,068
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce962

GMDN & GCC registration

  • GMDN code 43167 · implantable
  • Single‑use 99% · sterile 99% · Rx‑only 92% · 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) · 1,527Lumen/Inner Diameter (Millimeter) · 231Length (Millimeter) · 49

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

How many acetabular shell products are registered in the US?

6,106 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Acetabular shell", from 38 companies. The largest labeler is Biomet Orthopedics, Llc with 15% of records.

Which FDA product codes apply?

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