Cleared Traditional

K091196 - GRS GLENOID RESURFACING SYSTEM

K091196 is an FDA 510(k) clearance for GRS GLENOID RESURFACING SYSTEM, manufactured by Arthrosurface, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K091196 · Arthrosurface, Inc. · Orthopedic device
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Oct 2009
Decision
187d
Days
Class 2
Risk

K091196 is an FDA 510(k) clearance for the GRS GLENOID RESURFACING SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on October 27, 2009 after a review of 187 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Arthrosurface, Inc. devices

FDA 510(k) Submission Details - K091196

510(k) Number K091196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2009
Decision Date October 27, 2009
Days to Decision 187 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
65d slower than avg
Panel avg: 122d · This submission: 187d
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 K091196.
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ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
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