Cleared Traditional

K071948 - AEQUALIS REVERSED ADAPTER

K071948 is the FDA 510(k) clearance for AEQUALIS REVERSED ADAPTER by Tornier. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K071948 · Tornier · Orthopedic device
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Oct 2007
Decision
97d
Days
Class 2
Risk

K071948 is an FDA 510(k) clearance for the AEQUALIS REVERSED ADAPTER. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Tornier (Saint-Ismier Cedex, FR). The FDA issued a Cleared decision on October 18, 2007 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 K071948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2007
Decision Date October 18, 2007
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.
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 - PHX Shoulder Prosthesis, Reverse Configuration

All 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K071948.
EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
K073688 · Exactech, Inc. · Feb 2008
DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP
K073676 · DePuy Orthopaedics, Inc. · Jan 2008
COMPREHENSIVE RS SHOULDER SYSTEM
K072804 · Biomet Manufacturing Corp · Dec 2007
DELTA XTEND REVERSE SHOULDER MODULAR STEM
K071379 · DePuy Orthopaedics, Inc. · Sep 2007
EQUINOXE REVERSE SHOULDER SYSTEM
K063569 · Exactech, Inc. · Feb 2007
DELTA XTEND REVERSE SHOULDER SYSTEM
K062250 · DePuy Orthopaedics, Inc. · Feb 2007