Consulting Wallah › Device Explorer › Orthopaedic implants › Posterior-stabilized total knee prosthesis
Device Explorer · FDA GUDID · GMDN 33665

Posterior-stabilized total knee prosthesis

A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative joint [total knee arthroplasty (TKA)] or for prosthesis revision; it is implanted when the posterior cruciate l

US‑registered devices3,735in commercial distribution
Companies14labelers on GUDID
Single‑use96%of device records
Sterile96%labelled sterile
Prescription96%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

United Orthopedic Corp.1,00527%
Shalby Advanced Technologies, Inc.58516%
Microport Orthopedics Inc.56715%
Kyocera Medical Technologies, Inc.3088%
Encore Medical, L.P.3038%
B-One Ortho, Corp.2396%
Total Joint Orthopedics, Inc.1895%
Biomet Orthopedics, Llc1795%

Top labelers

CompanyDevicesShare
United Orthopedic Corp.1,00527%
Shalby Advanced Technologies, Inc.58516%
Microport Orthopedics Inc.56715%
Kyocera Medical Technologies, Inc.3088%
Encore Medical, L.P.3038%
B-One Ortho, Corp.2396%
Total Joint Orthopedics, Inc.1895%
Biomet Orthopedics, Llc1795%
Cpm Medical Consultants, Llc1735%
Novosource, Llc772%
Modal Manufacturing Llc461%
Meril Healthcare Private Limited401%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SLK EvoAGC V2 TOTAL KNEE SYSTEMU2 Total Knee SystemE-XPE Tibial insert, PSAE-XPE Tibial insert, PSE-XPE PatellaE-XPE Patellar, on set, 3 pegsXPE Tibial insert, PSA, LCXPE Tibial insert, PSAOffset stem adapterU2 Femoral component, CR, cementedU2 Femoral component, CR, porous coatedU2 Femoral component, PSXPE Tibial insert, PSTibial insert, PSU2 tibial baseplate, CMA

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

FDA product codes

CodeNameDevices
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem2,465
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM1,837
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem587
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, 344
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem321
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN275

GMDN & GCC registration

  • GMDN code 33665 · implantable
  • Single‑use 96% · sterile 96% · 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) · 656Length (Millimeter) · 165Width (Millimeter) · 24Outer Diameter (Millimeter) · 2

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

How many posterior-stabilized total knee prosthesis products are registered in the US?

3,735 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Posterior-stabilized total knee prosthesis", from 14 companies. The largest labeler is United Orthopedic Corp. with 27% of records.

Which FDA product codes apply?

JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, )

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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