Consulting Wallah › Device Explorer › Orthopaedic implants › Shoulder humeral body prosthesis
Device Explorer · FDA GUDID · GMDN 60512

Shoulder humeral body prosthesis

A sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a mod

US‑registered devices314in commercial distribution
Companies13labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Arthrosurface Incorporated6922%
Exactech, Inc.6220%
Implantcast Gmbh3611%
Depuy (Ireland)289%
Zimmer Gmbh248%
Fx Solutions175%
Ascension Orthopedics, Inc.165%
Smith & Nephew, Inc.155%

Top labelers

CompanyDevicesShare
Arthrosurface Incorporated6922%
Exactech, Inc.6220%
Implantcast Gmbh3611%
Depuy (Ireland)289%
Zimmer Gmbh248%
Fx Solutions175%
Ascension Orthopedics, Inc.165%
Smith & Nephew, Inc.155%
Arthrex, Inc.114%
Waldemar Link Gmbh & Co. Kg93%
Biomet Orthopedics, Llc93%
Tornier, Inc.93%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PROMOSAGILON®AGILON® metaphyseal component omarthrosisAGILON® metaphyseal component traumaAGILON® metaphyseal component omarthrosis incl. AGILON® metaphyseal component trauma incl. safetEmbrace Shoulder SystemHumeris ShoulderHumelock II Cemented Shoulder SystemAnatomical Shoulder™ Domelock®Anatomical Shoulder™ Bigliani/Flatow®Arthrex®Titan Modular Shoulder System 2.5Comprehensive® SRSTornier HRSTornier Perform Humeral System

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 UNCEMENTED169
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT164
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented139
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE49
PHXshoulder prosthesis, reverse configuration42
PAOprosthesis, shoulder, semi-constrained, metal/polymer + addi31

GMDN & GCC registration

  • GMDN code 60512 · 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) · 78Angle (degree) · 3Height (Millimeter) · 1

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

How many shoulder humeral body prosthesis products are registered in the US?

314 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Shoulder humeral body prosthesis", from 13 companies. The largest labeler is Arthrosurface Incorporated with 22% of records.

Which FDA product codes apply?

HSD (PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED), KWS (PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT), HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), KWT (PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE)

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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