Cleared Special

K140452 - VEGA KNEE SYSTEM

K140452 is an FDA 510(k) clearance for VEGA KNEE SYSTEM, manufactured by Aesculap Implant Systems. The device is a Class 2 Orthopedic device with product code JWH cleared through the Special 510(k) pathway after a 29-day FDA review.

K140452 · Aesculap Implant Systems · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
29d
Days
Class 2
Risk

K140452 is an FDA 510(k) clearance for the VEGA KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Aesculap Implant Systems (Center Valley, US). The FDA issued a Cleared decision on March 25, 2014 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aesculap Implant Systems devices

FDA 510(k) Submission Details - K140452

510(k) Number K140452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2014
Decision Date March 25, 2014
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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

All 842
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K140452.
ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER
K140027 · Materialise NV · May 2014
KLASSIC KNEE TIBIAL STEM EXTENSION
K140942 · Total Joint Orthopedics, Inc. · May 2014
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
K133560 · Conformis, Inc. · Mar 2014
ULTRACONGRUENT INSERT
K132752 · United Orthopedic Corporation · Mar 2014
ARTHREX IBALANCE TKA SYSTEM
K133854 · Arthrex, Inc. · Feb 2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA
K133162 · Materialise NV · Feb 2014