Consulting Wallah › Device Explorer › Orthopaedic implants › Unicondylar knee prosthesis
Device Explorer · FDA GUDID · GMDN 34195

Unicondylar knee prosthesis

A sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial comp

US‑registered devices1,577in commercial distribution
Companies16labelers on GUDID
Single‑use97%of device records
Sterile99%labelled sterile
Prescription96%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Uk Ltd26317%
Mako Surgical Corp.24115%
Smith & Nephew, Inc.18111%
Arthrex, Inc.1429%
Howmedica Osteonics Corp.1208%
Signature Orthopaedics Pty Ltd1177%
Kyocera Medical Technologies, Inc.1147%
Biomet Orthopedics, Llc1077%

Top labelers

CompanyDevicesShare
Biomet Uk Ltd26317%
Mako Surgical Corp.24115%
Smith & Nephew, Inc.18111%
Arthrex, Inc.1429%
Howmedica Osteonics Corp.1208%
Signature Orthopaedics Pty Ltd1177%
Kyocera Medical Technologies, Inc.1147%
Biomet Orthopedics, Llc1077%
Encore Medical, L.P.835%
Engage Uni Llc755%
Arthrosurface Incorporated564%
Maxx Orthopedics, Inc.382%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MakoTriathlonOxford® Partial Knee SystemOxford Partial Knee SystemOXFORD PARTIAL KNEE SYSTEMGENESIS IIOXINIUMDJO SURGICALArthrex®ENGAGENo BrandNO BRANDLegionJOURNEY IILEGIONJOURNEY

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, M620
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 486
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, M395
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTE372
NPJPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAI360
NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Const141

GMDN & GCC registration

  • GMDN code 34195 · implantable
  • Single‑use 97% · sterile 99% · Rx‑only 96% · 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) · 192Width (Millimeter) · 23Outer Diameter (Millimeter) · 15Length (Millimeter) · 14

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

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

1,577 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Unicondylar knee prosthesis", from 16 companies. The largest labeler is Biomet Uk Ltd with 17% of records.

Which FDA product codes apply?

HSX (PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, M), HRY (PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, ), HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, M), KRR (PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTE)

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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