Cleared Traditional

K994393 - AEQUALIS UNIVERSAL SHOULDER GLENOID

K994393 is an FDA 510(k) clearance for AEQUALIS UNIVERSAL SHOULDER GLENOID, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K994393 · Tornier · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2000
Decision
177d
Days
Class 2
Risk

K994393 is an FDA 510(k) clearance for the AEQUALIS UNIVERSAL SHOULDER GLENOID. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Tornier (Pleasant Hill, US). The FDA issued a Cleared decision on June 22, 2000 after a review of 177 days - an extended review cycle.

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

FDA 510(k) Submission Details - K994393

510(k) Number K994393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date June 22, 2000
Days to Decision 177 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
55d slower than avg
Panel avg: 122d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

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 183
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K994393.
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K003728 · Tornier · Dec 2000
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
K002683 · Wrightmedicaltechnologyinc · Nov 2000
WMT MODULAR SHOULDER SYSTEM
K001706 · Wrightmedicaltechnologyinc · Aug 2000
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
K001046 · Biopro, Inc. · Jun 2000
NEER III TOTAL SHOULDER SYSTEM
K994350 · Smith & Nephew, Inc. · May 2000
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
K000575 · DePuy Orthopaedics, Inc. · Mar 2000