Cleared Traditional

K151008 - LINK® MEGASYSTEM-C®

K151008 is an FDA 510(k) clearance for LINK MEGASYSTEM-C, manufactured by Waldemar Link GmbH & Co. KG. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K151008 · Waldemar Link GmbH & Co. KG · Orthopedic device
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Aug 2015
Decision
133d
Days
Class 2
Risk

K151008 is an FDA 510(k) clearance for the LINK® MEGASYSTEM-C®. 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 August 26, 2015 after a review of 133 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 Waldemar Link GmbH & Co. KG devices

FDA 510(k) Submission Details - K151008

510(k) Number K151008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2015
Decision Date August 26, 2015
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRO Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K151008.
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Smith and Nephew Legion Hinge Knee System
K151118 · Smith & Nephew · Jul 2015
PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
K140900 · Stanmore Worldwide Implants , Ltd. · Feb 2015
Zimmer Segmental System XT Components
K150028 · Zimmer, Inc. · Feb 2015