Cleared Traditional

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System

K233980 · Depuy Ireland UC · Orthopedic
Mar 2024
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K233980 is an FDA 510(k) clearance for the ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on March 21, 2024, 94 days after receiving the submission on December 18, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K233980 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2023
Decision Date March 21, 2024
Days to Decision 94 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

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