Consulting Wallah › Device Explorer › Orthopaedic implants › Revision coated hip femur prosthesis
Device Explorer · FDA GUDID · GMDN 34032

Revision coated hip femur prosthesis

A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, ne

US‑registered devices944in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription96%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medacta International Sa29932%
Zimmer, Inc.18319%
Shalby Advanced Technologies, Inc.13414%
Howmedica Osteonics Corp.748%
Biomet Orthopedics, Llc718%
United Orthopedic Corp.687%
Encore Medical, L.P.586%
Microport Orthopedics Inc.364%

Top labelers

CompanyDevicesShare
Medacta International Sa29932%
Zimmer, Inc.18319%
Shalby Advanced Technologies, Inc.13414%
Howmedica Osteonics Corp.748%
Biomet Orthopedics, Llc718%
United Orthopedic Corp.687%
Encore Medical, L.P.586%
Microport Orthopedics Inc.364%
Limacorporate Spa212%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RestorationUTS Stem, Ti plasma spray, high offsetUTS Stem, Ti plasma sprayUnited Hip System, UTF Stem, Reduced, Ti Plasma UTF stem, reduced, Ti plasma sprayUnited Hip System, UTF Stem, Reduced, Ti Plasma UTF Stem, reduced, Ti plasma spray, high offsetU2 Hip Stem, Ti Porous Coated, MatrixUnited Hip System, UTF Stem, Ti Plasma Spray, HiUnited Hip System, UTF Stem, Ti Plasma SprayU1 Hip System, Hip Stem, Porous Coated, CollarleU1 Hip System, Hip Stem, With Collar Porous CoatZMR®Trabecular Metal®DJO SURGICALREACH® REVISION 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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented395
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce391
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce281
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC274
KWZProsthesis, hip, constrained, cemented or uncemented, metal/181
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented181

GMDN & GCC registration

  • GMDN code 34032 · implantable
  • Single‑use 100% · 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

Outer Diameter (Millimeter) · 115Length (Millimeter) · 27Length (Micrometer) · 1

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

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

944 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Revision coated hip femur prosthesis", from 9 companies. The largest labeler is Medacta International Sa with 32% of records.

Which FDA product codes apply?

JDI (Prosthesis, hip, semi-constrained, metal/polymer, cemented), LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce), 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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