Consulting Wallah › Device Explorer › Orthopaedic implants › Coated hip femur prosthesis, modular
Device Explorer · FDA GUDID · GMDN 33581

Coated hip femur prosthesis, modular

A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a

US‑registered devices4,111in commercial distribution
Companies25labelers on GUDID
Single‑use95%of device records
Sterile98%labelled sterile
Prescription90%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Orthopedics, Llc66016%
Signature Orthopaedics Pty Ltd46111%
Smith & Nephew, Inc.43611%
Waldemar Link Gmbh & Co. Kg3649%
Encore Medical, L.P.3619%
United Orthopedic Corp.3238%
Zimmer Gmbh2486%
Zimmer, Inc.2255%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc66016%
Signature Orthopaedics Pty Ltd46111%
Smith & Nephew, Inc.43611%
Waldemar Link Gmbh & Co. Kg3649%
Encore Medical, L.P.3619%
United Orthopedic Corp.3238%
Zimmer Gmbh2486%
Zimmer, Inc.2255%
Corin Ltd1915%
Ortho Development Corporation1704%
Omni Life Science, Inc.1504%
Howmedica Osteonics Corp.1233%

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

Brand names on the register (sample)

InsigniaABGSecur-FitAccoladeAnatoPOLARSTEMSL-PLUS/INTEGRATION-PLUSIcona Hip StemMetafix Hip StemCorin TriFit CF Hip StemTriFit TS Blade StemC-Fit Femoral Hip SystemCorin Metafix Hip StemTRIFIT STEMMiniHip StemRIGI-FIX Series II

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

FDA product codes

CodeNameDevices
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce1,716
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC1,375
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce1,207
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or 1,023
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented1,016
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer989

GMDN & GCC registration

  • GMDN code 33581 · implantable
  • Single‑use 95% · sterile 98% · Rx‑only 90% · 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) · 42Length (Millimeter) · 31

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

How many coated hip femur prosthesis, modular products are registered in the US?

4,111 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coated hip femur prosthesis, modular", from 25 companies. The largest labeler is Biomet Orthopedics, Llc with 16% of records.

Which FDA product codes apply?

LZO (Prosthesis, hip, semi-constrained, metal/ceramic/polymer, ce), LPH (PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC), LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce), KWY (Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or )

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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