Cleared Traditional

K952928 - AEQUALIS SHOULDER SYSTEM FOR TOTAL & HE...

K952928 is the FDA 510(k) clearance for AEQUALIS SHOULDER SYSTEM FOR TOTAL & HE... by Tornier. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K952928 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
93d
Days
Class 2
Risk

K952928 is an FDA 510(k) clearance for the AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Tornier (Concord, US). The FDA issued a Cleared decision on September 27, 1995 after a review of 93 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 K952928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1995
Decision Date September 27, 1995
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K952928.
OSTEONICS N2/VAC PACKAGING PROCESS
K955944 · Osteonics Corp. · Apr 1996
COFIED MODULAR SHOULDER SYSTEM
K955767 · Smith & Nephew Richards, Inc. · Apr 1996
OSTEONICS SHOULDER HUMERAL COMPONENTS
K955731 · Osteonics Corp. · Mar 1996
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
K950521 · Osteonics Corp. · Jun 1995
TOTAL SHOULDER PROSTHESIS
K950651 · Encore Orthopedics, Inc. · May 1995
SELECT(R) SHOULDER ALL POLY GLENOID
K935802 · Intermedics Orthopedics · May 1995