Cleared Traditional

LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating (K152431) - FDA 510(k) Clearance

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

K152431 · Waldemar Link GmbH & Co. KG · Orthopedic device
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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
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 52
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