Cleared Traditional

K112900 - SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS

K112900 is an FDA 510(k) clearance for SMR RESURFACING SHOULDER SYSTEM- HUMERA..., manufactured by Lima Corporate S.P.A.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K112900 · Lima Corporate S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K112900

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
Combination Product No
PCCP Authorized No
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.

HSD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 66
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K112900.
ARTHREX UNIVERS II CA HEADS
K130675 · Arthrex, Inc. · Oct 2013
SEVIIN SURFACE REPLACEMENT SHOULDER
K130635 · Ingen Orthopedics, LLC · Aug 2013
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · Smith & Nephew, Inc. · Sep 2012
SPACER-S
K112983 · Tecres S.P.A. · Dec 2011
HUMELOCK CEMENTED SHOULDER PROSTHESIS
K111097 · Fx Solutions · Nov 2011
DEPUY GLOBAL AP CTA HUMERAL HEAD
K082715 · DePuy Orthopaedics, Inc. · Dec 2008