Cleared Traditional

K153722 - SMR 3-Pegs Glenoids

K153722 is an FDA 510(k) clearance for SMR 3-Pegs Glenoids, 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 100-day FDA review.

K153722 · Lima Corporate S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
100d
Days
Class 2
Risk

K153722 is an FDA 510(k) clearance for the SMR 3-Pegs Glenoids. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Villanova Di San Daniele Del Friuli, IT). The FDA issued a Cleared decision on April 6, 2016 after a review of 100 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 - K153722

510(k) Number K153722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2015
Decision Date April 06, 2016
Days to Decision 100 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
22d faster than avg
Panel avg: 122d · This submission: 100d
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 Consultant

Peoples & Associates Consulting, LLC
Stephen Peoples

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K153722.
BLUEPRINT Patient Specific Instrumentation
K160555 · Tornier S.A.S. · Jun 2016
Aequalis PerFORM+ Shoulder System
K160975 · Tornier, Inc. · Jun 2016
Materialise Glenoid Positioning System
K153602 · Materialise NV · Apr 2016
Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
K160085 · Zimmer GmbH · Mar 2016
SmartBase for Arthrex Glenoid IRIS
K153215 · Custom Orthopaedic Solutions, Inc. · Feb 2016
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
K152047 · Ascension Orthopedics · Dec 2015