Cleared Special

OvertureTi Knee Resurfacing SystemTM

K242746 · Overture Orthopaedics · Orthopedic

Oct 2024

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K242746 is an FDA 510(k) clearance for the OvertureTi Knee Resurfacing SystemTM, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Overture Orthopaedics (Irvine, US). The FDA issued a Cleared decision on October 7, 2024, 26 days after receiving the submission on September 11, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K242746 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2024
Decision Date	October 07, 2024
Days to Decision	26 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520