Cleared Traditional

K062661 - AEQUALIS RESURFACING HEAD

K062661 is the FDA 510(k) clearance for AEQUALIS RESURFACING HEAD by Tornier. It is a Class 2 Orthopedic device (product code HSD) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K062661 · Tornier · Orthopedic device
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Dec 2006
Decision
106d
Days
Class 2
Risk

K062661 is an FDA 510(k) clearance for the AEQUALIS RESURFACING HEAD. 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 December 22, 2006 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tornier devices

Submission Details

510(k) Number K062661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2006
Decision Date December 22, 2006
Days to Decision 106 days
Submission Type Traditional
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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K062661.
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
K080990 · DePuy Orthopaedics, Inc. · Aug 2008
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
K072578 · Synthes (Usa) · Nov 2007
REUNION HA FRACTURE STEM
K070963 · Howmedica Osteonics Corp. · May 2007
MODULAR REPLACEMENT ELBOW SYSTEM
K062845 · Howmedica Osteonics Corp. · Dec 2006
AEQUALIS SHOULDER SYSTEM
K063081 · Tornier · Nov 2006
SOLAR PUREFIX HA SHOULDER
K061677 · Howmedica Osteonics Corp. · Jul 2006