Cleared Traditional

Overture Orthopaedics Patellofemoral System

K231253 · Overture Resurfacing, Inc. · Orthopedic

Jul 2023

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K231253 is an FDA 510(k) clearance for the Overture Orthopaedics Patellofemoral System, a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRR), submitted by Overture Resurfacing, Inc. (New York, US). The FDA issued a Cleared decision on July 7, 2023, 67 days after receiving the submission on May 1, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3540.

Submission Details

510(k) Number	K231253 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2023
Decision Date	July 07, 2023
Days to Decision	67 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