Cleared Special

K122985 - COLUMBUS REVISION KNEE SYSTEM

K122985 is the FDA 510(k) clearance for COLUMBUS REVISION KNEE SYSTEM by Aesculap Implant System, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Special 510(k) pathway after a 30-day FDA review.

K122985 · Aesculap Implant System, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
30d
Days
Class 2
Risk

K122985 is an FDA 510(k) clearance for the COLUMBUS REVISION KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Aesculap Implant System, Inc. (Center Valley, US). The FDA issued a Cleared decision on October 26, 2012 after a review of 30 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 System, Inc. devices

Submission Details

510(k) Number K122985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2012
Decision Date October 26, 2012
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 763
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K122985.
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K122991 · Conformis, Inc. · Dec 2012
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
K121640 · Materialise NV · Dec 2012
PERSONA NATURAL TIBIA BASEPLATES
K122765 · Zimmer, Inc. · Nov 2012
GMK NARROW
K122232 · Medacta International · Sep 2012
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K122033 · Conformis, Inc. · Sep 2012
UNITY TOATAL KNEE SYSTEM
K113060 · Corin USA · Sep 2012