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OIY — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Class II

FDA Device Classification

Classification Details

Product Code
OIY
Device Class
Class II
Regulation Number
888.3560
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242665depuy orthopedicsDePuy ATTUNE™ Total Knee SystemNovember 1, 2024
K201347depuy orthopaedicsDePuy ATTUNE™ Total Knee SystemJune 18, 2020
K120038renovis surgical technologiesA200 KNEE SYSTEMFebruary 14, 2013
K121727encore medical, l.pMOVATION KNEE SYSTEMAugust 15, 2012
K113756encore medical, l.pHIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLMarch 14, 2012
K111433depuy orthopaedicsDEPUY STTUNE (TM) PS KNEE SYSTEMAugust 30, 2011
K103756depuy orthopaedicsDEPUY ATTUNE TOTAL KNEE SYSTEMMarch 15, 2011
K103223encore medical, l.pHIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTSDecember 21, 2010
K101433depuy orthopaedicsDEPUY ATTUNE KNEE SYSTEMDecember 10, 2010
K091956encore medical, l.pHIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712September 28, 2010
K100048biomet manufacturingE1 ANTIOXIDANT INFUSED TECHNOLOGYMarch 9, 2010