Cleared Traditional

K152431 - LINK Endo-Model Knee System with PorEx ...

K152431 is the FDA 510(k) clearance for LINK Endo-Model Knee System with PorEx ... by Waldemar Link GmbH & Co. KG. It is a Class 2 Orthopedic device (product code KRO) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K152431 · Waldemar Link GmbH & Co. KG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
257d
Days
Class 2
Risk

K152431 is an FDA 510(k) clearance for the LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System.... Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Waldemar Link GmbH & Co. KG (Hamburg, DE). The FDA issued a Cleared decision on May 9, 2016 after a review of 257 days - an extended review cycle.

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 Waldemar Link GmbH & Co. KG devices

Submission Details

510(k) Number K152431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2015
Decision Date May 09, 2016
Days to Decision 257 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
135d slower than avg
Panel avg: 122d · This submission: 257d
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 Peers - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 71
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K152431.
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
LINK® MEGASYSTEM-C®
K151008 · Waldemar Link GmbH & Co. KG · Aug 2015
Zimmer Segmental System XT Components
K150028 · Zimmer, Inc. · Feb 2015
The LINK® Endo-Model® Knee System
K143179 · Waldemar Link GmbH & Co. KG · Jan 2015