Consulting Wallah › Device Explorer › Orthopaedic implants › Coated femoral stem prosthesis, modular
Device Explorer · FDA GUDID · GMDN 34191

Coated femoral stem prosthesis, modular

A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium

US‑registered devices1,767in commercial distribution
Companies17labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Orthopedics, Llc44125%
Signature Orthopaedics Pty Ltd22713%
Exactech, Inc.22012%
Shalby Advanced Technologies, Inc.1619%
Nextstep Arthropedix, Llc1488%
Kyocera Medical Technologies, Inc.1056%
Microport Orthopedics Inc.845%
Limacorporate Spa684%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc44125%
Signature Orthopaedics Pty Ltd22713%
Exactech, Inc.22012%
Shalby Advanced Technologies, Inc.1619%
Nextstep Arthropedix, Llc1488%
Kyocera Medical Technologies, Inc.1056%
Microport Orthopedics Inc.845%
Limacorporate Spa684%
Smith & Nephew, Inc.644%
Iconacy Orthopedic Implants Llc543%
Amplitude Sas473%
Cpm Medical Consultants, Llc463%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MRSGMRSSTRATUS StemSTRATUS Stem - High Offset - Collared - Size 18STRATUS Stem - High Offset - Collared - Size 16STRATUS Stem - High Offset - Collared - Size 15STRATUS Stem - High Offset - Collared - Size 14STRATUS Stem - High Offset - Collared - Size 13STRATUS Stem - High Offset - Collared - Size 12STRATUS Stem - High Offset - Collared - Size 11STRATUS Stem - High Offset - Collared - Size 10STRATUS Stem - High Offset - Collared - Size 9NAANTHOLOGYAnthology AFITSMF

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

FDA product codes

CodeNameDevices
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC587
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc587
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce429
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce417
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer392
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented368

GMDN & GCC registration

  • GMDN code 34191 · implantable
  • Single‑use 99% · sterile 99% · 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) · 161Width (Millimeter) · 38Length (Millimeter) · 23

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

How many coated femoral stem prosthesis, modular products are registered in the US?

1,767 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coated femoral stem prosthesis, modular", from 17 companies. The largest labeler is Biomet Orthopedics, Llc with 25% of records.

Which FDA product codes apply?

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