Cleared Traditional

K102670 - TOTAL SHOULDER SYSTEM

K102670 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 Traditional 510(k) pathway after a 130-day FDA review.

K102670 · Shoulder Innovations, LLC · Orthopedic device
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Jan 2011
Decision
130d
Days
Class 2
Risk

K102670 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 January 24, 2011 after a review of 130 days - within the typical 510(k) review window.

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 Shoulder Innovations, LLC devices

FDA 510(k) Submission Details - K102670

510(k) Number K102670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2010
Decision Date January 24, 2011
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
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 166
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K102670.
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