Cleared Traditional

K040432 - SOLAR 2 ANATOMIC SHOULDER (FDA 510(k) Clearance)

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

K040432 · Stryker Orthopaedics · Orthopedic device
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Jan 2005
Decision
323d
Days
Class 2
Risk

K040432 is an FDA 510(k) clearance for the SOLAR 2 ANATOMIC SHOULDER. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on January 7, 2005 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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 Stryker Orthopaedics devices

Submission Details

510(k) Number K040432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2004
Decision Date January 07, 2005
Days to Decision 323 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
201d slower than avg
Panel avg: 122d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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.