Cleared Traditional

K110847 - SMR SHOULDER SYSTEM - CTA HUMERAL HEADS

K110847 is an FDA 510(k) clearance for SMR SHOULDER SYSTEM - CTA HUMERAL HEADS, 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 109-day FDA review.

K110847 · Lima Corporate S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
109d
Days
Class 2
Risk

K110847 is an FDA 510(k) clearance for the SMR SHOULDER SYSTEM - CTA HUMERAL HEADS. 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 15, 2011 after a review of 109 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 - K110847

510(k) Number K110847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2011
Decision Date July 15, 2011
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
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 K110847.
EXACTECH EQUINOXE CAGE GLENOIDS
K113309 · Exactech, Inc. · Dec 2011
AEQUALIS SHOULDER SYSTEM
K111902 · Tornier · Nov 2011
SMR SHOULDER SYSTEM- REVISION STEMS
K111212 · 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
TOTAL SHOULDER SYSTEM
K110905 · Shoulder Innovations, LLC · May 2011