Cleared Traditional

K070981 - SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM...

K070981 is an FDA 510(k) clearance for SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM..., manufactured by Aesculap Implant Systems, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K070981 · Aesculap Implant Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
137d
Days
Class 2
Risk

K070981 is an FDA 510(k) clearance for the SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE). Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Aesculap Implant Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on August 21, 2007 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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, Inc. devices

FDA 510(k) Submission Details - K070981

510(k) Number K070981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2007
Decision Date August 21, 2007
Days to Decision 137 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
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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

Aesculap AG
Kathy Racosky

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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 813
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K070981.
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
K071071 · Smith & Nephew, Inc. · Sep 2007
COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY
K071499 · Aesculap Implant Systems, Inc. · Sep 2007
NEXGEN PROLONG ALL-POLY PATELLA
K072281 · Zimmer, Inc. · Sep 2007
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
K071738 · Exactech, Inc. · Aug 2007
MODIFICATION TO SCORPIO NRG KNEE SYSTEM
K071991 · Howmedica Osteonics Corp. · Aug 2007
TRIATHLON TS KNEE SYSTEM
K070095 · Howmedica Osteonics Corp. · Jun 2007