Cleared Traditional

K150730 - Zimmer PSI Shoulder System

K150730 is an FDA 510(k) clearance for Zimmer PSI Shoulder System, manufactured by Zimmer. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K150730 · Zimmer · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2015
Decision
88d
Days
Class 2
Risk

K150730 is an FDA 510(k) clearance for the Zimmer PSI Shoulder System. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Zimmer (Montreal, CA). The FDA issued a Cleared decision on June 16, 2015 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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 Zimmer devices

FDA 510(k) Submission Details - K150730

510(k) Number K150730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2015
Decision Date June 16, 2015
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWT Device Classification - Class 2, Special Controls

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 66
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K150730.
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
K162903 · Exactech, Inc. · Feb 2017
SMR Shoulder System
K161476 · Lima Corporate S.P.A. · Jun 2016
Catalyst CSR Shoulder System
K152825 · Catalyst Orthoscience, LLC · May 2016
Equinoxe Mega Prosthesis
K143659 · Exactech, Inc. · Apr 2015
HUMELOCK II CEMENTED SHOULDER SYSTEM
K140071 · Fx Solutions · Jul 2014
HUMELOCK II CEMENTED SHOULDER SYSTEM
K123814 · Fx Solutions · Aug 2013