Cleared Traditional

Attune Revision LPS Inserts (K191779) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191779 · Depuy(Ireland) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
98d
Days
Class 2
Risk

K191779 is an FDA 510(k) clearance for the Attune Revision LPS Inserts. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Depuy(Ireland) (Cork, IE). The FDA issued a Cleared decision on October 8, 2019 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Depuy(Ireland) devices

Submission Details

510(k) Number K191779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2019
Decision Date October 08, 2019
Days to Decision 98 days
Submission Type Traditional
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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 Consultant

Depuy Orthopaedies, Inc.
Soraya L. Hori

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 53
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K191779.
GMK Revision & Hinge Extension - TiNbN Coating
K210010 · Medacta International S.A. · Mar 2021
Zimmer Segmental System
K192798 · Zimmer, Inc. · Dec 2020
Instruments for LINK MEGASYSTEM-C Family
K190181 · LinkBio Corp. · Oct 2019
USTAR II System
K190100 · United Orthopedic Corporation · Sep 2019
GMK Hinge, GMK Revision
K172347 · Medacta International S.A. · Nov 2017
GMK Revision Femoral Distal Augmentation
K163311 · Medacta International S.A. · Dec 2016