Cleared Traditional

K043346 - GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00

K043346 is an FDA 510(k) clearance for GENESIS TOTAL SHOULDER REPLACEMENT, manufactured by Genesis Medical LLC. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K043346 · Genesis Medical LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
56d
Days
Class 2
Risk

K043346 is an FDA 510(k) clearance for the GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Genesis Medical LLC (Cranbury, US). The FDA issued a Cleared decision on January 31, 2005 after a review of 56 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 Genesis Medical LLC devices

FDA 510(k) Submission Details - K043346

510(k) Number K043346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2004
Decision Date January 31, 2005
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 169
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K043346.
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
K060209 · Tornier · Mar 2006
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
K052472 · DePuy Orthopaedics, Inc. · Oct 2005
ANATOMICAL SHOULDER KEELED GLENOID
K051623 · Zimmer GmbH · Jul 2005
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K043077 · Tornier · Dec 2004
EXACTECH EQUINOXE SHOULDER SYSTEM
K042021 · Exactech, Inc. · Oct 2004
AEQUALIS SHOULDER SYSTEM
K041339 · Tornier · Jun 2004