Cleared Traditional

K101815 - ENDURO KNEE SYSTEM

K101815 is an FDA 510(k) clearance for ENDURO KNEE SYSTEM, manufactured by Aesculap Implant Systems. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K101815 · Aesculap Implant Systems · Orthopedic device
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Dec 2010
Decision
173d
Days
Class 2
Risk

K101815 is an FDA 510(k) clearance for the ENDURO KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Aesculap Implant Systems (Center Valley, US). The FDA issued a Cleared decision on December 20, 2010 after a review of 173 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 Aesculap Implant Systems devices

FDA 510(k) Submission Details - K101815

510(k) Number K101815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2010
Decision Date December 20, 2010
Days to Decision 173 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
51d slower than avg
Panel avg: 122d · This submission: 173d
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 72
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K101815.
GMK HINGE
K130299 · Medacta International · Aug 2013
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K122015 · Howmedica Osteonics Corp. · Feb 2013
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
K110940 · Zimmer, Inc. · Jul 2011
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
K091453 · DePuy Orthopaedics, Inc. · Aug 2009
MAK OSS KNEE FEMORAL COMPONENTS
K083779 · Biomet Manufacturing Corp · Apr 2009
ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
K083827 · Biomet Manufacturing Corp · Feb 2009