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Device Explorer · FDA GUDID · GMDN 34223

Uncoated 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 not coated with materials intended to improve fixation and stability. The device may be made o

US‑registered devices266in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Howmedica Osteonics Corp.11945%
Medacta International Sa6625%
Zimmer, Inc.6123%
Corin Ltd208%

Top labelers

CompanyDevicesShare
Howmedica Osteonics Corp.11945%
Medacta International Sa6625%
Zimmer, Inc.6123%
Corin Ltd208%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Austin MooreF.R. ThompsonUnitraxCorin Austin Moore Fenestrated Prosthesis (CobalCPT®VerSys® Advocate® V-Lign®VerSys® Advocate®VerSys®Quadra P femoral stemsAMIStem C Femoral StemsQuadra C Femoral StemsQuadra C femoral stems

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KWLProsthesis, hip, hemi-, femoral, metal150
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented70
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented66
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce66
LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball18
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or 18

GMDN & GCC registration

  • GMDN code 34223 · 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

Outer Diameter (Millimeter) · 20

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

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

266 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uncoated hip femur prosthesis, one-piece", from 4 companies. The largest labeler is Howmedica Osteonics Corp. with 45% of records.

Which FDA product codes apply?

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

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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