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510(k) K041160

AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT by Howmedica Osteonics Corp. — Product Code KRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2004
Date Received
May 3, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3540
Review Panel
OR
Submission Type

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  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)
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  • K120578 — ACCOLADE II HIP STEM (March 29, 2012)

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  • K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System (June 14, 2018)
  • K160461 — Arthrex iBalance BiCompartmental Arthroplasty System (April 12, 2016)
  • K143543 — Prelude PF Patellae (January 30, 2015)
  • K123907 — PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST (September 3, 2013)
  • K111970 — KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT (February 23, 2012)
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