Consulting Wallah › Device Explorer › Orthopaedic implants › Metal-on-polyethylene total hip prosthesis
Device Explorer · FDA GUDID · GMDN 33181

Metal-on-polyethylene total hip prosthesis

A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devi

US‑registered devices2,223in commercial distribution
Companies12labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

United Orthopedic Corp.66430%
Maxx Orthopedics, Inc.61528%
Kyocera Medical Corporation33715%
Kyocera Corporation33715%
Ortho Development Corporation1004%
Modal Manufacturing Llc633%
Conformis, Inc.281%
Biopro, Inc.281%

Top labelers

CompanyDevicesShare
United Orthopedic Corp.66430%
Maxx Orthopedics, Inc.61528%
Kyocera Medical Corporation33715%
Kyocera Corporation33715%
Ortho Development Corporation1004%
Modal Manufacturing Llc633%
Conformis, Inc.281%
Biopro, Inc.281%
Medisurge Llc201%
Cpm Medical Consultants, Llc141%
Total Joint Orthopedics, Inc.100%
Globus Medical, Inc.70%

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

Brand names on the register (sample)

United Hip SystemU2 Femoral head, 4/5 polished, Ø36mm, +10mmU2 Femoral head, 4/5 polished, Ø36mm, +7.5mmU2 Femoral head, 4/5 polished, Ø36mm, +5mmU2 Femoral head, 4/5 polished, Ø36mm, +2.5mmU2 Femoral head, 4/5 polished, Ø36mm, +0mmU2 Femoral head, 4/5 polished, Ø36mm, -3mmU2 Femoral head, 4/5 polished, Ø32mm, +10mmU2 Femoral head, 4/5 polished, Ø32mm, +7.5mmU2 Femoral head, 4/5 polished, Ø32mm, +5mmU2 Femoral head, 4/5 polished, Ø32mm, +2.5mmU2 Femoral head, 4/5 polished, Ø32mm, +0mmU2 Femoral head, 4/5 polished, Ø32mm, -3mmU2 Femoral head, 4/5 polished, Ø28mm, +10mmU2 Femoral head, 4/5 polished, Ø28mm, +7.5mmU2 Femoral head, 4/5 polished, Ø28mm, +5mm

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 Unc1,271
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce691
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polym270
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented254
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce200
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented164

GMDN & GCC registration

  • GMDN code 33181 · implantable
  • Single‑use 100% · sterile 100% · 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) · 383Lumen/Inner Diameter (Millimeter) · 123Angle (degree) · 77Length (Millimeter) · 64Width (Millimeter) · 8

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

How many metal-on-polyethylene total hip prosthesis products are registered in the US?

2,223 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Metal-on-polyethylene total hip prosthesis", from 12 companies. The largest labeler is United Orthopedic Corp. with 30% 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), MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polym), 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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