Consulting Wallah › Device Explorer › Orthopaedic implants › Hip revision prosthesis trial
Device Explorer · FDA GUDID · GMDN 63525

Hip revision prosthesis trial

A copy of a final hip revision prosthesis, in the form of a combined femoral stem and head, designed to be used before revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation

US‑registered devices51in commercial distribution
Companies5labelers on GUDID
Single‑use10%of device records
Sterile10%labelled sterile
Prescription47%Rx‑only share
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Share of device records

Adler Ortho Spa2447%
Biocomposites Ltd1224%
Tecres Spa1020%
Heraeus Medical Gmbh48%
G21 Srl12%

Top labelers

CompanyDevicesShare
Adler Ortho Spa2447%
Biocomposites Ltd1224%
Tecres Spa1020%
Heraeus Medical Gmbh48%
G21 Srl12%

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

Brand names on the register (sample)

COPAL® exchange GSynicem Hip Spacer Trial Case (marked) XLSynicem Hip Spacer Trial Case (marked) RegularSynicem 56CXL Hip Trial FDASynicem Hip Trial 48CXL FDASynicem Hip Trial 40CXL FDASynicem 56M Hip Trial FDASynicem 56C Hip Trial FDASynicem 48M Hip Trial FDASynicem 48C Hip Trial FDASynicem 40C Hip Trial FDASynicem Hip Spacer Trial Tray XL with TrialsSynicem Hip Spacer Trial Tray Regular with TrialSpaceFlex Hip TrialTrial stemTrial shaft

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

FDA product codes

CodeNameDevices
LXHOrthopedic Manual Surgical Instrument34
HWTTemplate15

GMDN & GCC registration

  • GMDN code 63525 · non‑implantable
  • Single‑use 10% · sterile 10% · Rx‑only 47% · 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 hip revision prosthesis trial 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 "Hip revision prosthesis trial", from 5 companies. The largest labeler is Adler Ortho Spa with 47% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), HWT (Template)

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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