Cleared Traditional

K111212 - SMR SHOULDER SYSTEM- REVISION STEMS

K111212 is an FDA 510(k) clearance for SMR SHOULDER SYSTEM- REVISION STEMS, manufactured by Lima Corporate S.P.A.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K111212 · Lima Corporate S.P.A. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2011
Decision
90d
Days
Class 2
Risk

K111212 is an FDA 510(k) clearance for the SMR SHOULDER SYSTEM- REVISION STEMS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Winona Lake, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 90 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 Lima Corporate S.P.A. devices

FDA 510(k) Submission Details - K111212

510(k) Number K111212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2011
Decision Date July 28, 2011
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 185
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K111212.
PROMOS MODULAR SHOULDER SYSTEM
K113012 · Smith & Nephew, Inc. · Jan 2012
EXACTECH EQUINOXE CAGE GLENOIDS
K113309 · Exactech, Inc. · Dec 2011
AEQUALIS SHOULDER SYSTEM
K111902 · Tornier · Nov 2011
SMR SHOULDER SYSTEM - CTA HUMERAL HEADS
K110847 · Lima Corporate S.P.A. · Jul 2011
TOTAL SHOULDER SYSTEM
K111596 · Shoulder Innovations, LLC · Jul 2011
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
K111379 · Exactech, Inc. · Jun 2011