Consulting Wallah › Device Explorer › Orthopaedic implants › Press-fit hip femur prosthesis, one-piece
Device Explorer · FDA GUDID · GMDN 55834

Press-fit hip femur prosthesis, one-piece

A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is one-piece and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natur

US‑registered devices1,160in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medacta International Sa50944%
Microport Orthopedics Inc.33929%
Global Manufacturing Technology Pty Limited726%
Depuy (Ireland)605%
Ortho Development Corporation464%
Novosource, Llc464%
Total Joint Orthopedics, Inc.424%
Signal Medical Corporation262%

Top labelers

CompanyDevicesShare
Medacta International Sa50944%
Microport Orthopedics Inc.33929%
Global Manufacturing Technology Pty Limited726%
Depuy (Ireland)605%
Ortho Development Corporation464%
Novosource, Llc464%
Total Joint Orthopedics, Inc.424%
Signal Medical Corporation262%
Depuy Orthopaedics, Inc.202%

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

Brand names on the register (sample)

TrivictaKlassic Blade Offset Femoral StemKlassic Blade Femoral StemKlassic Blade Offset Femoral Stem, Porous, Size Klassic Blade Offset Femoral Stem, Porous, Size Klassic Blade Offset Femoral Stem, Porous, Size Klassic Blade Offset Femoral Stem, Porous, Size Klassic Blade Offset Femoral Stem, Porous, Size Klassic Blade Offset Femoral Stem, Porous, Size Klassic Blade Offset Femoral Stem, Porous, Size Klassic Blade Offset Femoral Stem, Porous, Size Klassic Blade Offset Femoral Stem, Porous, Size Klassic Blade Femoral Stem, Porous, Size 9Klassic Blade Femoral Stem, Porous, Size 8Klassic Blade Femoral Stem, Porous, Size 7Klassic Blade Femoral Stem, Porous, Size 6

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, Ce715
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc349
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented293
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer240
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce204
LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball151

GMDN & GCC registration

  • GMDN code 55834 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · 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) · 34Length (Millimeter) · 23

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

How many press-fit hip femur prosthesis, one-piece products are registered in the US?

1,160 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Press-fit hip femur prosthesis, one-piece", from 9 companies. The largest labeler is Medacta International Sa with 44% 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), MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer)

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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