Consulting Wallah › Device Explorer › Orthopaedic implants › Stem-fixed metallic humeral head prosthesis
Device Explorer · FDA GUDID · GMDN 48088

Stem-fixed metallic humeral head prosthesis

An implantable artificial substitute for a diseased or injured humeral head. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid f

US‑registered devices1,008in commercial distribution
Companies18labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Orthopedics, Llc14214%
Tornier12312%
Zimmer, Inc.10410%
Limacorporate Spa9610%
Tornier, Inc.818%
Depuy Orthopaedics, Inc.656%
Exactech, Inc.576%
Fx Solutions566%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc14214%
Tornier12312%
Zimmer, Inc.10410%
Limacorporate Spa9610%
Tornier, Inc.818%
Depuy Orthopaedics, Inc.656%
Exactech, Inc.576%
Fx Solutions566%
Depuy (Ireland)535%
Stryker Gmbh525%
Smith & Nephew, Inc.525%
Ascension Orthopedics, Inc.404%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MRSREUNIONPROMOSAGILON® XO CTA capAGILON® XO capFX V135 Shoulder ProsthesisTiN Coated Humeral HeadHumelock Reversed ShoulderHumeris ShoulderHumelock Cemented Shoulder SystemHumelock II Cemented Shoulder SystemHumelock Cemented Shoulder ProsthesisTornier Flex Shoulder SystemAEQUALISDuocentric®Identity™

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

FDA product codes

CodeNameDevices
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT813
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED663
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE461
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEM229
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented209
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente135

GMDN & GCC registration

  • GMDN code 48088 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · 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) · 415Height (Millimeter) · 338Length (Millimeter) · 23Width (Millimeter) · 23

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

How many stem-fixed metallic humeral head prosthesis products are registered in the US?

1,008 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stem-fixed metallic humeral head prosthesis", from 18 companies. The largest labeler is Biomet Orthopedics, Llc with 14% of records.

Which FDA product codes apply?

KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), HSD (PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED), KWT (PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE), MBF (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEM)

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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