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Device Explorer · FDA GUDID · GMDN 60515

Combination-material acetabulum prosthesis

A sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made of a combination of metal, ceramic, and/or polyethylene (PE); it m

US‑registered devices99in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile98%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Howmedica Osteonics Corp.7778%
Maxx Orthopedics, Inc.1919%
Onkos Surgical, Inc.22%
Zimmer, Inc.11%

Top labelers

CompanyDevicesShare
Howmedica Osteonics Corp.7778%
Maxx Orthopedics, Inc.1919%
Onkos Surgical, Inc.22%
Zimmer, Inc.11%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TridentOmnifitNALibertasMy3D® Personalized Pelvic Reconstruction

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 UNC35
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce35
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented34
KWZProsthesis, hip, constrained, cemented or uncemented, metal/9
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc2

GMDN & GCC registration

  • GMDN code 60515 · implantable
  • Single‑use 100% · sterile 98% · Rx‑only 100% · 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) · 68Outer Diameter (Millimeter) · 43

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

How many combination-material acetabulum prosthesis products are registered in the US?

99 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Combination-material acetabulum prosthesis", from 4 companies. The largest labeler is Howmedica Osteonics Corp. with 78% 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), JDI (Prosthesis, hip, semi-constrained, metal/polymer, cemented), KWZ (Prosthesis, hip, constrained, cemented or uncemented, 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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