Consulting Wallah › Device Explorer › Orthopaedic implants › Revision uncoated femoral stem prosthesis
Device Explorer · FDA GUDID · GMDN 34038

Revision uncoated femoral stem prosthesis

A sterile implantable device designed to replace the proximal femoral neck during replacement of a total hip prosthesis typically due to wear. The device is composed of two or more separate segments designed to be joined (modular), is made of metal [e.g., coba

US‑registered devices75in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Limacorporate Spa3445%
Adler Ortho Spa3040%
Biomet Orthopedics, Llc1115%

Top labelers

CompanyDevicesShare
Limacorporate Spa3445%
Adler Ortho Spa3040%
Biomet Orthopedics, Llc1115%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PLR HIP SYSTEMPantheon SystemPantheon PFR SystemREVISIONC2 REVISION Hip

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, Ce64
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc56
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented42
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 34
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer30
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented11

GMDN & GCC registration

  • GMDN code 34038 · implantable
  • Single‑use 100% · sterile 100% · 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

Length (Millimeter) · 23

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

How many revision uncoated femoral stem prosthesis products are registered in the US?

75 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Revision uncoated femoral stem prosthesis", from 3 companies. The largest labeler is Limacorporate Spa with 45% 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), JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), 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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