Consulting Wallah › Device Explorer › Orthopaedic implants › Femoral head/stem prosthesis adaptor
Device Explorer · FDA GUDID · GMDN 59688

Femoral head/stem prosthesis adaptor

A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralizati

US‑registered devices167in commercial distribution
Companies12labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Microport Orthopedics Inc.4326%
Ortho Development Corporation2817%
Biomet Orthopedics, Llc2616%
Depuy Orthopaedics, Inc.2113%
Howmedica Osteonics Corp.148%
Signature Orthopaedics Pty Ltd117%
Exactech, Inc.74%
Smith & Nephew, Inc.42%

Top labelers

CompanyDevicesShare
Microport Orthopedics Inc.4326%
Ortho Development Corporation2817%
Biomet Orthopedics, Llc2616%
Depuy Orthopaedics, Inc.2113%
Howmedica Osteonics Corp.148%
Signature Orthopaedics Pty Ltd117%
Exactech, Inc.74%
Smith & Nephew, Inc.42%
Stinson Orthopedics Inc.42%
Novosource, Llc42%
Medacta International Sa42%
Total Joint Orthopedics, Inc.11%

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

Brand names on the register (sample)

SleeveBIOLOX OPTION HIP SYSTEMBioloxAdapter SleeveBIOLOX® OPTION Head SystemNAStageOne SelectBIO-MOORE ENDO II HIP SYSTEMMANZA HEADSSolitude UnipolarFemoral Head Adapter Sleeve for BIOLOX OPTION FeNovosource Total Hip SystemProfemurPROFEMUR®MICROPORTBIOLOX

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, ce66
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce48
KWLProsthesis, hip, hemi-, femoral, metal36
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC23
LZYProsthesis, hip, hemi-, femoral, metal ball21
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer20

GMDN & GCC registration

  • GMDN code 59688 · 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) · 28Length (Millimeter) · 4

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

How many femoral head/stem prosthesis adaptor products are registered in the US?

167 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Femoral head/stem prosthesis adaptor", from 12 companies. The largest labeler is Microport Orthopedics Inc. with 26% 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), KWL (Prosthesis, hip, hemi-, femoral, metal), 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.

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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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