Cleared Special

K012212 - MODIFICATION TO AEQUALIS SHOULDER SYSTEM

K012212 is the FDA 510(k) clearance for MODIFICATION TO AEQUALIS SHOULDER SYSTEM by Tornier. It is a Class 2 Orthopedic device (product code KWS) cleared through the Special 510(k) pathway after a 30-day FDA review.

K012212 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
30d
Days
Class 2
Risk

K012212 is an FDA 510(k) clearance for the MODIFICATION TO AEQUALIS SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Tornier (Montbonnot, FR). The FDA issued a Cleared decision on August 15, 2001 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 Tornier devices

Submission Details

510(k) Number K012212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date August 15, 2001
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 152
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K012212.
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II
K012788 · Smith & Nephew, Inc. · Mar 2002
3D HUMERAL HEADS
K012378 · Smith & Nephew, Inc. · Dec 2001
PLASMA SPRAYED SHOULDER
K003324 · Encore Orthopedics, Inc. · Dec 2001
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
K010124 · Arthrex, Inc. · Apr 2001
ANATOMICAL PRESS-FIT HUMERAL STEM
K003801 · Sulzer Orthopedics, Inc. · Feb 2001
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
K003566 · Smith & Nephew, Inc. · Feb 2001