Consulting Wallah › Device Explorer › Other devices › Bipolar femoral head outer component, total arthro
Device Explorer · FDA GUDID · GMDN 65063

Bipolar femoral head outer component, total arthroplasty

An implantable hemisphere-shaped device used as part of a total hip arthroplasty (THA) and designed to interface with the acetabular liner on its outer surface where it freely rotates, and encompass/interface with a femoral head prosthesis on its inner surface

US‑registered devices62in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Maxx Orthopedics, Inc.5487%
Encore Medical, L.P.813%

Top labelers

CompanyDevicesShare
Maxx Orthopedics, Inc.5487%
Encore Medical, L.P.813%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LibertasDJO SURGICAL

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

FDA product codes

CodeNameDevices
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce54
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC8

GMDN & GCC registration

  • GMDN code 65063 · implantable
  • Single‑use 100% · sterile 100% · 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 bipolar femoral head outer component, total arthroplasty products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bipolar femoral head outer component, total arthroplasty", from 2 companies. The largest labeler is Maxx Orthopedics, Inc. with 87% of records.

Which FDA product codes apply?

LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Ce), LPH (PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC)

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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