FDA.reportPublic FDA data

STERIZO Total Knee System

Primary DI
B565M340100801
Brand
STERIZO Total Knee System
Company
CPM Medical Consultants, LLC
Model
Rev A
Catalog number
M-3401-0080
Device description
Patella 35mm
Published
2022-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142649000
K150783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142649000Progressive Orthopedic Total Knee SystemThe Progressive Orthopaedic Company, LLC2015-03-24JWH
K150783000Progressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLC2015-06-23JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B565M340100801PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-stabilized total knee prosthesisA 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 ligament is sacrificed and uses a “cam and post†mechanism to replace the stabilizing function of the ligament. It includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implanted with or without bone cement and is often used in cases where bone stock and mediolateral stability are good in the face of severe deformities or ligament degeneration.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
972-331-5860xx@xx.xx

Regulatory Flags#

DUNS number
017138000
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B565OS328028L1Fuse ULTRA FOOT PLATING SYSTEMOS328028LOS328028L2026-04-17
B565M32205016L1STERIZO Total Knee SystemM-3220-5016LM-3220-5016L2026-02-26
B565M32205016S1STERIZO Total Knee SystemM-3220-5016SM-3220-5016S2026-02-26
B565OS20160960Fuse ULTRA FOOT PLATING SYSTEMOS2016096OS20160962025-05-29
B565OS4225081Fuse ULTRA FOOT PLATING SYSTEMOS422508OS4225082025-08-01
B565OS4225101Fuse ULTRA FOOT PLATING SYSTEMOS422510OS4225102025-08-01
B565OS4225121Fuse ULTRA FOOT PLATING SYSTEMOS422512OS4225122025-08-01
B565OS4225141Fuse ULTRA FOOT PLATING SYSTEMOS422514OS4225142025-08-01
B565OS4225161Fuse ULTRA FOOT PLATING SYSTEMOS422516OS4225162025-08-01
B565OS4225181Fuse ULTRA FOOT PLATING SYSTEMOS422518OS4225182025-08-01
B565OS4225201Fuse ULTRA FOOT PLATING SYSTEMOS422520OS4225202025-08-01
B565OS4225221Fuse ULTRA FOOT PLATING SYSTEMOS422522OS4225222025-08-01
B565OS4225241Fuse ULTRA FOOT PLATING SYSTEMOS422524OS4225242025-08-01
B565OS4225261Fuse ULTRA FOOT PLATING SYSTEMOS422526OS4225262025-08-01
B565OS4225281Fuse ULTRA FOOT PLATING SYSTEMOS422528OS4225282025-08-01
B565OS4225301Fuse ULTRA FOOT PLATING SYSTEMOS422530OS4225302025-08-01
B565OS4226081Fuse ULTRA FOOT PLATING SYSTEMOS422608OS4226082025-08-01
B565OS4226101Fuse ULTRA FOOT PLATING SYSTEMOS422610OS4226102025-08-01
B565OS4226121Fuse ULTRA FOOT PLATING SYSTEMOS422612OS4226122025-08-01
B565OS4226141Fuse ULTRA FOOT PLATING SYSTEMOS422614OS4226142025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08906067247254Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247261Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247278Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247285Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247292Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247308Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247315Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247322Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247339Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247346Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247353Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247360Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247377Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247384Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247391Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247407Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247414Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247421Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247438Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247445Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247452Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247469Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247476Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247483Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247490Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247506Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247513Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247520Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247537Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05