Cleared Special

K063081 - AEQUALIS SHOULDER SYSTEM

K063081 is an FDA 510(k) clearance for AEQUALIS SHOULDER SYSTEM, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code HSD cleared through the Special 510(k) pathway after a 30-day FDA review.

K063081 · Tornier · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
30d
Days
Class 2
Risk

K063081 is an FDA 510(k) clearance for the AEQUALIS SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Tornier (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on November 9, 2006 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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 - K063081

510(k) Number K063081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2006
Decision Date November 09, 2006
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.

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 K063081.
PROMOS MODULAR SHOULDER SYSTEM
K063578 · Plus Orthopedics AG · Mar 2007
AEQUALIS RESURFACING HEAD
K062661 · Tornier · Dec 2006
MODULAR REPLACEMENT ELBOW SYSTEM
K062845 · Howmedica Osteonics Corp. · Dec 2006
ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
K062861 · Ascension Orthopedics, Inc. · Oct 2006
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
K061862 · Axiom Orthopaedics, Inc. · Aug 2006
SOLAR PUREFIX HA SHOULDER
K061677 · Howmedica Osteonics Corp. · Jul 2006
K063081 · AEQUALIS SHOULDER SYSTEM
Download PDF FDA Summary Tornier