Consulting Wallah › Device Explorer › Orthopaedic implants › Rotating hinged total knee prosthesis
Device Explorer · FDA GUDID · GMDN 33692

Rotating hinged total knee prosthesis

A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour res

US‑registered devices962in commercial distribution
Companies8labelers on GUDID
Single‑use99%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

United Orthopedic Corp.24325%
Depuy (Ireland)20121%
Howmedica Osteonics Corp.18519%
Waldemar Link Gmbh & Co. Kg12713%
Smith & Nephew, Inc.9810%
Microport Orthopedics Inc.798%
Biomet Orthopedics, Llc222%
Onkos Surgical, Inc.71%

Top labelers

CompanyDevicesShare
United Orthopedic Corp.24325%
Depuy (Ireland)20121%
Howmedica Osteonics Corp.18519%
Waldemar Link Gmbh & Co. Kg12713%
Smith & Nephew, Inc.9810%
Microport Orthopedics Inc.798%
Biomet Orthopedics, Llc222%
Onkos Surgical, Inc.71%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TriathlonTRIATHLONKinematicMRHKinemaxGMRSMRSUSTAR II Knee System"""UNITED"" USTAR II Knee System""""UNITED"" USTAR II Knee System "Tibial mainbody, RHS, STibial mainbody, RHS, XSTibial baseplate, #6Tibial baseplate, #5Tibial baseplate, #4Tibial baseplate, #3

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

FDA product codes

CodeNameDevices
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL604
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal345
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented249
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Unc243
KWLProsthesis, Hip, Hemi-, Femoral, Metal243
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM120

GMDN & GCC registration

  • GMDN code 33692 · 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

Length (Millimeter) · 8

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

No closely related category with 50+ devices.

How many rotating hinged total knee prosthesis products are registered in the US?

962 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rotating hinged total knee prosthesis", from 8 companies. The largest labeler is United Orthopedic Corp. with 25% of records.

Which FDA product codes apply?

KRO (PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL), KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal), LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), 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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