Cleared Special

K110905 - TOTAL SHOULDER SYSTEM

K110905 is an FDA 510(k) clearance for TOTAL SHOULDER SYSTEM, manufactured by Shoulder Innovations, LLC. The device is a Class 2 Orthopedic device with product code KWS cleared through the Special 510(k) pathway after a 54-day FDA review.

K110905 · Shoulder Innovations, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
54d
Days
Class 2
Risk

K110905 is an FDA 510(k) clearance for the TOTAL SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Shoulder Innovations, LLC (Ada, US). The FDA issued a Cleared decision on May 24, 2011 after a review of 54 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shoulder Innovations, LLC devices

FDA 510(k) Submission Details - K110905

510(k) Number K110905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2011
Decision Date May 24, 2011
Days to Decision 54 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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 166
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K110905.
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