Cleared Special

PINNACLETM Constrained Acetabular Liners

K240639 · Depuy Ireland UC · Orthopedic

Apr 2024

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K240639 is an FDA 510(k) clearance for the PINNACLETM Constrained Acetabular Liners, a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II — Special Controls, product code KWZ), submitted by Depuy Ireland UC (Cork, GB). The FDA issued a Cleared decision on April 4, 2024, 29 days after receiving the submission on March 6, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3310.

Submission Details

510(k) Number	K240639 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2024
Decision Date	April 04, 2024
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3310