Consulting Wallah › Device Explorer › Orthopaedic implants › Shoulder reverse/standard adaptor prosthesis trial
Device Explorer · FDA GUDID · GMDN 61005

Shoulder reverse/standard adaptor prosthesis trial

A copy of a final shoulder reverse/standard adaptor prosthesis designed to be used before revision implant surgery to validate the appropriate size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is

US‑registered devices86in commercial distribution
Companies4labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Catalyst Orthoscience Inc.5260%
Arthrex, Inc.2428%
Limacorporate Spa78%
Restor3D, Inc.33%

Top labelers

CompanyDevicesShare
Catalyst Orthoscience Inc.5260%
Arthrex, Inc.2428%
Limacorporate Spa78%
Restor3D, Inc.33%

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

Brand names on the register (sample)

Arthrex®Veritas Reverse Total ShoulderReverse Shoulder SystemF1x Fracture Stem SystemEA Convertible SystemR1 Reverse Shoulder SystemPRIMA TT Glenoid

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

FDA product codes

CodeNameDevices
PHXShoulder Prosthesis, Reverse Configuration54
HWTTEMPLATE20
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented18
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement10
LXHOrthopedic Manual Surgical Instrument7
LXHOrthopedic manual surgical instrument4

GMDN & GCC registration

  • GMDN code 61005 · non‑implantable
  • Single‑use 3% · sterile 0% · 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

No structured size data on the register.

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

How many shoulder reverse/standard adaptor prosthesis trial products are registered in the US?

86 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Shoulder reverse/standard adaptor prosthesis trial", from 4 companies. The largest labeler is Catalyst Orthoscience Inc. with 60% of records.

Which FDA product codes apply?

PHX (Shoulder Prosthesis, Reverse Configuration), HWT (TEMPLATE), HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), 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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