Cleared Traditional

K143552 - Simpliciti Shoulder System

K143552 is the FDA 510(k) clearance for Simpliciti Shoulder System by Tornier, Inc.. It is a Class 2 Orthopedic device (product code PKC) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K143552 · Tornier, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2015
Decision
79d
Days
Class 2
Risk

K143552 is an FDA 510(k) clearance for the Simpliciti Shoulder System. Classified as Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (product code PKC), Class II - Special Controls.

Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on March 4, 2015 after a review of 79 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tornier, Inc. devices

Submission Details

510(k) Number K143552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2014
Decision Date March 04, 2015
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01390038 Completed Interventional Industry-sponsored

Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty

Simpliciti IDE Trial

157
Patients (actual)
14
Sites
Treatment
Purpose
Open label
Masking
Condition studied Primary Generalized (Osteo)Arthritis; Post-traumatic Arthrosis of Other Joints, Upper Arm
Study design Single group
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Sponsor Stryker Trauma and Extremities (industry)
Started 2011-07-01 → Primary completion 2014-11-01 → Completed 2014-12-01
Primary outcome
Device Success Rate
Secondary outcome
Quality of Life
View full study on ClinicalTrials.gov