Cleared Special

K011942 - AEQUALIS PRESS-FIT SHOULDER PROSTHESIS

K011942 is an FDA 510(k) clearance for AEQUALIS PRESS-FIT SHOULDER PROSTHESIS, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code HSD cleared through the Special 510(k) pathway after a 22-day FDA review.

K011942 · Tornier · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
22d
Days
Class 2
Risk

K011942 is an FDA 510(k) clearance for the AEQUALIS PRESS-FIT SHOULDER PROSTHESIS. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Tornier (St. Ismier, FR). The FDA issued a Cleared decision on July 13, 2001 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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.

FDA 510(k) Submission Details - K011942

510(k) Number K011942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2001
Decision Date July 13, 2001
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

HSD Device Classification - Class 2, Special Controls

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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 - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 70
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K011942.
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
K012377 · Corin USA · Mar 2002
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · Biomet Manufacturing, Inc. · Sep 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827 · Biomet Orthopedics, Inc. · Sep 2001
COPELAND RESURFACING HUMERAL HEADS
K010664 · Biomet Manufacturing, Inc. · Apr 2001
COPELAND RESURFACING HEADS
K003044 · Biomet, Inc. · Dec 2000
ISS OFFSET HEADS
K003428 · Biomet, Inc. · Nov 2000
K011942 · AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
Download PDF FDA Summary Tornier