510(k) K103223

HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS by Encore Medical, L.P. — Product Code OIY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 21, 2010
Date Received: November 1, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Device Class: Class II
Regulation Number: 888.3560
Review Panel: OR
Submission Type

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.

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Other clearances for product code OIY

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K120038 — A200 KNEE SYSTEM (February 14, 2013)
K121727 — MOVATION KNEE SYSTEM (August 15, 2012)
K113756 — HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELL (March 14, 2012)
K111433 — DEPUY STTUNE (TM) PS KNEE SYSTEM (August 30, 2011)
K103756 — DEPUY ATTUNE TOTAL KNEE SYSTEM (March 15, 2011)
K101433 — DEPUY ATTUNE KNEE SYSTEM (December 10, 2010)
K091956 — HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 (September 28, 2010)
K100048 — E1 ANTIOXIDANT INFUSED TECHNOLOGY (March 9, 2010)