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Device Explorer · FDA GUDID · GMDN 61002

Humeral head spacer

A sterile implantable component of a total shoulder prosthesis intended to be placed between a standard humeral body and a standard humeral head to serve as a spacer and to achieve the intended varus/valgus alignment. It is in the form of a thick disc with a c

US‑registered devices51in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Tornier, Inc.2549%
Limacorporate Spa1835%
Waldemar Link Gmbh & Co. Kg510%
Fx Solutions24%
Fx Shoulder Solutions, Inc.12%

Top labelers

CompanyDevicesShare
Tornier, Inc.2549%
Limacorporate Spa1835%
Waldemar Link Gmbh & Co. Kg510%
Fx Solutions24%
Fx Shoulder Solutions, Inc.12%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LINK Embrace Shoulder SystemHUMERIS 135Humelock II Cemented Reversible ShoulderAequalis™ Adjustable ReversedFX V135SMR SystemPRIMASMR STEMLESS

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 UNCEMENTED30
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT30
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTE30
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented17
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemente16
PHXShoulder Prosthesis, Reverse Configuration7

GMDN & GCC registration

  • GMDN code 61002 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 98% · 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) · 25Length (Millimeter) · 25Angle (degree) · 1

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

No closely related category with 50+ devices.

How many humeral head spacer products are registered in the US?

51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Humeral head spacer", from 5 companies. The largest labeler is Tornier, Inc. with 49% of records.

Which FDA product codes apply?

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

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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