Cleared Traditional

K093599 - ARROW ANATOMICAL SHOULDER SYSTEM

K093599 is an FDA 510(k) clearance for ARROW ANATOMICAL SHOULDER SYSTEM, manufactured by Fournitures Hospitalieres Industrie. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 369-day FDA review.

K093599 · Fournitures Hospitalieres Industrie · Orthopedic device
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Nov 2010
Decision
369d
Days
Class 2
Risk

K093599 is an FDA 510(k) clearance for the ARROW ANATOMICAL SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Fournitures Hospitalieres Industrie (Quimper Finistere, FR). The FDA issued a Cleared decision on November 24, 2010 after a review of 369 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Fournitures Hospitalieres Industrie devices

FDA 510(k) Submission Details - K093599

510(k) Number K093599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2009
Decision Date November 24, 2010
Days to Decision 369 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
247d slower than avg
Panel avg: 122d · This submission: 369d
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 156
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K093599.
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K102924 · Tornier, Inc. · Jan 2011
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K103466 · Arthrex, Inc. · Dec 2010
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
K103419 · Exactech, Inc. · Dec 2010
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
K103104 · Howmedica Osteonics Corp. · Nov 2010
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
K103007 · Tornier, Inc. · Nov 2010
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
K093430 · Exactech, Inc. · Sep 2010