510(k) K100048

E1 ANTIOXIDANT INFUSED TECHNOLOGY by Biomet Manufacturing Corp — Product Code OIY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 9, 2010
Date Received: January 8, 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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K173411 — Comprehensive Segmental Revision System (SRS) (February 8, 2018)
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K163651 — ExpressBraid Graft Manipulation (February 17, 2017)

Other clearances for product code OIY

K242665 — DePuy ATTUNE Total Knee System (November 1, 2024)
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K120038 — A200 KNEE SYSTEM (February 14, 2013)
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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)
K103223 — HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS (December 21, 2010)
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)