Consulting Wallah › Device Explorer › Orthopaedic implants › Ceramic femoral head prosthesis
Device Explorer · FDA GUDID · GMDN 38156

Ceramic femoral head prosthesis

An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to art

US‑registered devices1,296in commercial distribution
Companies36labelers on GUDID
Single‑use99%of device records
Sterile100%labelled sterile
Prescription94%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Smith & Nephew, Inc.15012%
Limacorporate Spa1209%
Zimmer, Inc.1139%
Encore Medical, L.P.625%
Zimmer Gmbh595%
Depuy Orthopaedics, Inc.584%
Signature Orthopaedics Pty Ltd574%
Howmedica Osteonics Corp.474%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.15012%
Limacorporate Spa1209%
Zimmer, Inc.1139%
Encore Medical, L.P.625%
Zimmer Gmbh595%
Depuy Orthopaedics, Inc.584%
Signature Orthopaedics Pty Ltd574%
Howmedica Osteonics Corp.474%
Microport Orthopedics Inc.474%
Corentec Co., Ltd403%
Orthomedflex Llc383%
Exactech, Inc.373%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BioloxAluminaBiolox Delta Modular Head 36mm EXTRA LONG +8.0mmBiolox Delta Modular Head 32mm EXTRA LONG +7.0mmBiolox Delta Modular Head 36mm LONG +4.0mm 12/14Biolox Delta Modular Head 36mm MEDIUM 0.0mm 12/1Biolox Delta Modular Head 36mm SHORT -4.0mm 12/1Biolox Delta Modular Head 32mm LONG +4.0mm 12/14Biolox Delta Modular Head 32mm MEDIUM 0.0mm 12/1Biolox Delta Modular Head 32mm SHORT -4.0mm 12/1Biolox Delta Modular Head 28mm LONG +3.5mm 12/14Biolox Delta Modular Head 28mm MEDUM 0.0mm 12/14Biolox Delta Modular Head 28mm SHORT -3.5mm 12/1Zyranox Zirconia Ceramic Femoral HeadsBiolox Delta Modular Head 40mm EXTRA LONG +8.0mmBiolox Delta Modular Head 40mm LONG +4.0mm 12/14

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, ce575
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce521
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc357
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC181
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer103
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or 90

GMDN & GCC registration

  • GMDN code 38156 · implantable
  • Single‑use 99% · sterile 100% · Rx‑only 94% · 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) · 281Angle (degree) · 31Length (Millimeter) · 7

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

How many ceramic femoral head prosthesis products are registered in the US?

1,296 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ceramic femoral head prosthesis", from 36 companies. The largest labeler is Smith & Nephew, Inc. with 12% of records.

Which FDA product codes apply?

LZO (Prosthesis, hip, semi-constrained, metal/ceramic/polymer, ce), LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce), LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc), LPH (PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC)

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.

How do I get quotes?

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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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