Cleared Special

K240639 - PINNACLETM Constrained Acetabular Liners

K240639 is an FDA 510(k) clearance for PINNACLETM Constrained Acetabular Liners, manufactured by Depuy Ireland UC. The device is a Class 2 Orthopedic device with product code KWZ cleared through the Special 510(k) pathway after a 29-day FDA review.

K240639 · Depuy Ireland UC · Orthopedic device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Apr 2024

Decision

29d

Days

Class 2

Risk

K240639 is an FDA 510(k) clearance for the PINNACLETM Constrained Acetabular Liners. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (product code KWZ), Class II - Special Controls.

Submitted by Depuy Ireland UC (Cork, GB). The FDA issued a Cleared decision on April 4, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3310 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K240639

510(k) Number	K240639 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

93d faster than avg

Panel avg: 122d · This submission: 29d

Pathway characteristics

Modification to existing cleared device.

KWZ Device Classification - Class 2, Special Controls

Product Code	KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 888.3310

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

All 33

Devices cleared under the same product code (KWZ) and FDA review panel - the closest regulatory comparables to K240639.

Mpact Constrained Liner

K241461 · Medacta International S.A. · Jul 2025

Smith & Nephew, Inc. R3™ Constrained Liner

K162641 · Smith & Nephew, Inc. · Jun 2017

EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt

K163497 · Encore Medical, L.P. · Mar 2017

EXPRT Revision Hip System

K161610 · Encore Medical, L.P. · Nov 2016

SMITH & NEPHEW R3 CONSTRAINED LINERS

K122139 · Smith & Nephew, Inc. · Oct 2012

SMITH & NEPHEW RJ CONSTRAINED LINERS

K111635 · Smith & Nephew, Inc. · Sep 2011

FDA 510(k) Resources - Orthopedic

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.