Cleared Traditional

K112900 - SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K112900 · Lima Corporate S.P.A. · Orthopedic device
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Jun 2012
Decision
242d
Days
Class 2
Risk

K112900 is an FDA 510(k) clearance for the SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Winona Lake, US). The FDA issued a Cleared decision on June 1, 2012 after a review of 242 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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

Submission Details

510(k) Number K112900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date June 01, 2012
Days to Decision 242 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
120d slower than avg
Panel avg: 122d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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.