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510(k) K091956

HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 by Encore Medical, L.P. — Product Code OIY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2010
Date Received
July 1, 2009
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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  • 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)
  • K100048 — E1 ANTIOXIDANT INFUSED TECHNOLOGY (March 9, 2010)