Cleared Traditional

Episealer Patellofemoral System

K221048 · Episurf Medical, Inc. · Orthopedic

Dec 2022

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K221048 is an FDA 510(k) clearance for the Episealer Patellofemoral System, a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRR), submitted by Episurf Medical, Inc. (New York, US). The FDA issued a Cleared decision on December 23, 2022, 259 days after receiving the submission on April 8, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3540.

Submission Details

510(k) Number	K221048 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2022
Decision Date	December 23, 2022
Days to Decision	259 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