Cleared Traditional

Avon Patello-femoral Joint Prosthesis

K211303 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic

Jun 2021

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K211303 is an FDA 510(k) clearance for the Avon Patello-femoral Joint Prosthesis, a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRR), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on June 4, 2021, 36 days after receiving the submission on April 29, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3540.

Submission Details

510(k) Number	K211303 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2021
Decision Date	June 04, 2021
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KRR — Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3540