Consulting Wallah › Device Explorer › Orthopaedic implants › Uncoated femoral stem prosthesis, modular
Device Explorer · FDA GUDID · GMDN 34203

Uncoated femoral stem prosthesis, modular

A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), s

US‑registered devices147in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription90%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Microport Orthopedics Inc.6846%
Implants International Ltd3624%
Kyocera Medical Technologies, Inc.1812%
Encore Medical, L.P.1410%
Implantcast Gmbh96%
Biomet Orthopedics, Llc21%

Top labelers

CompanyDevicesShare
Microport Orthopedics Inc.6846%
Implants International Ltd3624%
Kyocera Medical Technologies, Inc.1812%
Encore Medical, L.P.1410%
Implantcast Gmbh96%
Biomet Orthopedics, Llc21%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PerformaStabilityMUTARS®MUTARS® femoral stem cementedDJO SURGICALOSS™ Orthopedic Salvage SystemKyocera Medical Technologies, Inc.PROFEMUR®ProfemurPerfectaGUARDIAN®

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, Cemented133
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc40
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce28
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Met15
JDGProsthesis, Hip, Femoral Component, Cemented, Metal14
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal11

GMDN & GCC registration

  • GMDN code 34203 · implantable
  • Single‑use 100% · sterile 100% · 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

Length (Millimeter) · 46Outer Diameter (Millimeter) · 15

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

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

147 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uncoated femoral stem prosthesis, modular", from 6 companies. The largest labeler is Microport Orthopedics Inc. with 46% of records.

Which FDA product codes apply?

JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc), LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce), MRA (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Met)

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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