510(k) K211303

Avon Patello-femoral Joint Prosthesis by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code KRR

K211303 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Avon Patello-femoral Joint Prosthesis". The FDA issued a decision of Substantially Equivalent on June 4, 2021. The device falls under product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3540. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2021
Date Received
April 29, 2021
Clearance Type
Traditional
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