Cleared Traditional

K980244 - AEQUALIS SHOULDER PROSTHESIS

K980244 is the FDA 510(k) clearance for AEQUALIS SHOULDER PROSTHESIS by Tornier. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 577-day FDA review.

K980244 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
577d
Days
Class 2
Risk

K980244 is an FDA 510(k) clearance for the AEQUALIS SHOULDER PROSTHESIS. 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 August 23, 1999 after a review of 577 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Tornier devices

Submission Details

510(k) Number K980244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1998
Decision Date August 23, 1999
Days to Decision 577 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
455d slower than avg
Panel avg: 122d · This submission: 577d
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 K980244.
AEQUALIS SHOULDER FRACTURE SYSTEM
K994392 · Tornier · Mar 2000
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
K992899 · Biomet, Inc. · Oct 1999
BIO-MODULAR SHOULDER SYSTEM
K992119 · Biomet, Inc. · Sep 1999
GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD
K992065 · DePuy Orthopaedics, Inc. · Jul 1999
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
K990598 · Howmedica Osteonics Corp. · Mar 1999
ANATOMICA GLENOID COMPONENT
K990136 · Sulzer Orthopedics, Inc. · Mar 1999