Consulting Wallah › Device Explorer › Orthopaedic implants › Cruciate-retaining total knee prosthesis
Device Explorer · FDA GUDID · GMDN 33664

Cruciate-retaining total knee prosthesis

A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative (e.g., arthritic) joint [total knee arthroplasty (TKA)]; it is designed to be implanted with retention of the p

US‑registered devices2,557in commercial distribution
Companies17labelers on GUDID
Single‑use94%of device records
Sterile99%labelled sterile
Prescription79%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

United Orthopedic Corp.75029%
Encore Medical, L.P.42917%
Optimotion Implants Llc32013%
Cpm Medical Consultants, Llc2078%
Kyocera Medical Technologies, Inc.1968%
B-One Ortho, Corp.1104%
Endotec, Inc.1054%
Arthrex, Inc.904%

Top labelers

CompanyDevicesShare
United Orthopedic Corp.75029%
Encore Medical, L.P.42917%
Optimotion Implants Llc32013%
Cpm Medical Consultants, Llc2078%
Kyocera Medical Technologies, Inc.1968%
B-One Ortho, Corp.1104%
Endotec, Inc.1054%
Arthrex, Inc.904%
Implanet803%
Modal Manufacturing Llc783%
Novosource, Llc773%
Smith & Nephew, Inc.341%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TC-PLUSAGC V2 TOTAL KNEE SYSTEMU2 Total Knee SystemE-XPE Tibial insert, CRE-XPE PatellaE-XPE Patellar, on set, 3 pegsCellbrick Knee SpacerU2 Femoral component, CR, cementedU2 Femoral component, CR, porous coatedU2 Femoral component, PSTibial insert, PSU2 tibial baseplate, CMAXPE Patellar, On set, 3 pegsXPE PatellaXPE Tibial Insert, CRTibial Baseplate, PSA type, Screw locking

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, Cem2,096
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem731
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM612
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un561
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN204
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem183

GMDN & GCC registration

  • GMDN code 33664 · implantable
  • Single‑use 94% · sterile 99% · Rx‑only 79% · 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) · 146Width (Millimeter) · 46Length (Millimeter) · 16Outer Diameter (Millimeter) · 2

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

How many cruciate-retaining total knee prosthesis products are registered in the US?

2,557 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cruciate-retaining total knee prosthesis", from 17 companies. The largest labeler is United Orthopedic Corp. with 29% of records.

Which FDA product codes apply?

JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un)

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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