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510(k) K113756

HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA by Encore Medical, L.P. — Product Code OIY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2012
Date Received
December 21, 2011
Clearance Type
Special
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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  • K233481 — AltiVate Reverse® Glenoid (May 29, 2024)
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Other clearances for product code OIY

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  • K201347 — DePuy ATTUNE™ Total Knee System (June 18, 2020)
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  • K121727 — MOVATION KNEE SYSTEM (August 15, 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)
  • K100048 — E1 ANTIOXIDANT INFUSED TECHNOLOGY (March 9, 2010)