Consulting Wallah › Device Explorer › Orthopaedic implants › Uncoated femoral stem prosthesis, one-piece
Device Explorer · FDA GUDID · GMDN 33989

Uncoated femoral stem prosthesis, one-piece

A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials inte

US‑registered devices477in commercial distribution
Companies12labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription96%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Orthopedics, Llc16835%
Exactech, Inc.7917%
Signature Orthopaedics Pty Ltd7015%
Shalby Advanced Technologies, Inc.6514%
Depuy (Ireland)265%
Orthomedflex Llc214%
Depuy Orthopaedics, Inc.133%
Smith & Nephew, Inc.123%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc16835%
Exactech, Inc.7917%
Signature Orthopaedics Pty Ltd7015%
Shalby Advanced Technologies, Inc.6514%
Depuy (Ireland)265%
Orthomedflex Llc214%
Depuy Orthopaedics, Inc.133%
Smith & Nephew, Inc.123%
Globus Medical, Inc.112%
Microport Orthopedics Inc.102%
Biomet Spine Llc10%
Conformis, Inc.10%

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

Brand names on the register (sample)

ECHELONBi-Metric® Hip SystemSirius® Hip SystemBi-Metric® Revision Hip SystemBiomet® Omega 21™ Spinal Fixation SystemSIRIUS HIP SYSTEMGENERATION 4 HIP SYSTEMECHO FX HIP SYSTEMFINN KNEE SYSTEMANSWER HIP SYSTEMBI-METRIC REVISION HIP SYSTEMBIO-MOORE II HIP SYSTEMRX90 REVISION HIP SYSTEMINTEGRAL CENTRALIZER HIP SYSTEMBI-METRIC HEAD/NECK HIP SYSTEMBI-METRIC INTERLOK 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
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce204
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented134
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce122
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented121
JDGProsthesis, hip, femoral component, cemented, metal73
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC69

GMDN & GCC registration

  • GMDN code 33989 · 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) · 73Length (Millimeter) · 47

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

How many uncoated femoral stem prosthesis, one-piece products are registered in the US?

477 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uncoated femoral stem prosthesis, one-piece", from 12 companies. The largest labeler is Biomet Orthopedics, Llc with 35% of records.

Which FDA product codes apply?

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