Consulting Wallah › Device Explorer › Orthopaedic implants › Acetabulum prosthesis trial, prefabricated, single
Device Explorer · FDA GUDID · GMDN 62303

Acetabulum prosthesis trial, prefabricated, single-use

A copy of a final acetabular cup prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typical

US‑registered devices105in commercial distribution
Companies3labelers on GUDID
Single‑use69%of device records
Sterile69%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Restor3D, Inc.6461%
Total Joint Orthopedics, Inc.3331%
Conformis, Inc.88%

Top labelers

CompanyDevicesShare
Restor3D, Inc.6461%
Total Joint Orthopedics, Inc.3331%
Conformis, Inc.88%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Velora Acetabular System InstrumentationAcetabular Cup SizerHooded Acetabular Insert TrialKlassic HD Acetabular Insert TrialKlassic BiPolar Sizing HandleCordera

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

FDA product codes

CodeNameDevices
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc72
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT33
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce8
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polym8
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, +8

GMDN & GCC registration

  • GMDN code 62303 · non‑implantable
  • Single‑use 69% · sterile 69% · Rx‑only 100% · 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 acetabulum prosthesis trial, prefabricated, single-use products are registered in the US?

105 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Acetabulum prosthesis trial, prefabricated, single-use", from 3 companies. The largest labeler is Restor3D, Inc. with 61% of records.

Which FDA product codes apply?

LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce), MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polym)

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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