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Device Explorer · FDA GUDID · GMDN 48070

Unicondylar knee insert

A sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).

US‑registered devices1,104in commercial distribution
Companies12labelers on GUDID
Single‑use99%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medacta International Sa32429%
Smith & Nephew, Inc.24522%
Zimmer, Inc.17015%
Depuy (Ireland)12011%
Biomet Orthopedics, Llc848%
Globus Medical, Inc.545%
Implantcast Gmbh303%
Biopro, Inc.242%

Top labelers

CompanyDevicesShare
Medacta International Sa32429%
Smith & Nephew, Inc.24522%
Zimmer, Inc.17015%
Depuy (Ireland)12011%
Biomet Orthopedics, Llc848%
Globus Medical, Inc.545%
Implantcast Gmbh303%
Biopro, Inc.242%
Conformis, Inc.202%
Medisurge Llc202%
Corin Ltd121%
Waldemar Link Gmbh & Co. Kg10%

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

Brand names on the register (sample)

Uniglide Unicondylar Knee ProsthesisUni FB PE-insertLINK Endo-Model EVO Knee SystemGENESISNAVivacit-E®Persona® Vivacit-E®ZUKJOURNEYSTRIDEJOURNEY IIPersona® Partial Knee SystemUnicondylar Knee SystemiUni® iPoly™ Insert KitiDuo® iPoly™ Insert KitSIGMA

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

FDA product codes

CodeNameDevices
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M523
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, M451
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 162
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem132
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, 76
NPJPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAI60

GMDN & GCC registration

  • GMDN code 48070 · implantable
  • Single‑use 99% · 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

Height (Millimeter) · 175

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

No closely related category with 50+ devices.

How many unicondylar knee insert products are registered in the US?

1,104 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Unicondylar knee insert", from 12 companies. The largest labeler is Medacta International Sa with 29% of records.

Which FDA product codes apply?

HSX (PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M), HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, M), HRY (PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, ), OIY (Prosthesis, knee, patellofemorotibial, semi-constrained, cem)

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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