Consulting Wallah › Device Explorer › Orthopaedic implants › Coated femoral stem prosthesis, one-piece
Device Explorer · FDA GUDID · GMDN 64708

Coated femoral stem prosthesis, one-piece

A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g.,

US‑registered devices503in 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

Depuy (Ireland)21743%
Depuy Orthopaedics, Inc.18737%
Conformis, Inc.6513%
Implantcast Gmbh347%

Top labelers

CompanyDevicesShare
Depuy (Ireland)21743%
Depuy Orthopaedics, Inc.18737%
Conformis, Inc.6513%
Implantcast Gmbh347%

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

Brand names on the register (sample)

implaFit® hip stem cementless lateralizedimplaFit® hip stem with collar cemented lateraliimplaFit® hip stem with collar cemented standardimplaFit® hip stem cementless standardACTERAACTERA HIP STEMACTISEMPHASYSCORAILSOLUTION SYSTEMSUMMIT POROCOATAMLTRI-LOCK GRIPTION

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 UNC269
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or 216
KWLProsthesis, hip, hemi-, femoral, metal216
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce185
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer109
MEHProsthesis, hip, semi-constrained, uncemented, metal / polym108

GMDN & GCC registration

  • GMDN code 64708 · 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

No structured size data on the register.

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

How many coated femoral stem prosthesis, one-piece products are registered in the US?

503 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Coated femoral stem prosthesis, one-piece", from 4 companies. The largest labeler is Depuy (Ireland) with 43% of records.

Which FDA product codes apply?

LPH (PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC), KWY (Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or ), KWL (Prosthesis, hip, hemi-, femoral, metal), 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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