Cleared Traditional

K043077 - MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM (FDA 510(k) Clearance)

Also includes:
AEQUALIS SHOULDER SYSTEM

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043077 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
39d
Days
Class 2
Risk

K043077 is an FDA 510(k) clearance for the MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Tornier (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on December 17, 2004 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tornier devices

Submission Details

510(k) Number K043077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2004
Decision Date December 17, 2004
Days to Decision 39 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 122d · This submission: 39d
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 189
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K043077.
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