Consulting Wallah › Device Explorer › Orthopaedic implants › Humeral stem extension prosthesis
Device Explorer · FDA GUDID · GMDN 61006

Humeral stem extension prosthesis

A sterile implantable component of a total shoulder prosthesis intended to be fixed to the proximal end of a humeral stem when there has been a large resection of the humerus (e.g., due to trauma or tumour) to achieve the additional length required for connect

US‑registered devices74in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Exactech, Inc.5777%
Biomet Orthopedics, Llc1216%
Implantcast Gmbh57%

Top labelers

CompanyDevicesShare
Exactech, Inc.5777%
Biomet Orthopedics, Llc1216%
Implantcast Gmbh57%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AGILON® extension pieceCompress® DeviceCOMPRESS DEVICEComprehensive® SRSEquinoxe

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

FDA product codes

CodeNameDevices
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented62
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente57
PHXShoulder Prosthesis, Reverse Configuration57
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement56
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED12
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE12

GMDN & GCC registration

  • GMDN code 61006 · 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) · 30Length (Millimeter) · 26

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

How many humeral stem extension prosthesis products are registered in the US?

74 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Humeral stem extension prosthesis", from 3 companies. The largest labeler is Exactech, Inc. with 77% of records.

Which FDA product codes apply?

HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente), PHX (Shoulder Prosthesis, Reverse Configuration), KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement)

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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