Cleared Traditional

K222317 - Catalyst EA Convertible Stemmed Shoulder

K222317 is an FDA 510(k) clearance for Catalyst EA Convertible Stemmed Shoulder, manufactured by Catalyst Orthoscience, Inc.. 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.

K222317 · Catalyst Orthoscience, Inc. · Orthopedic device
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Nov 2022
Decision
100d
Days
Class 2
Risk

K222317 is an FDA 510(k) clearance for the Catalyst EA Convertible Stemmed Shoulder. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Catalyst Orthoscience, Inc. (Naples, US). The FDA issued a Cleared decision on November 10, 2022 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 Catalyst Orthoscience, Inc. devices

FDA 510(k) Submission Details - K222317

510(k) Number K222317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2022
Decision Date November 10, 2022
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 Peers - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 156
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K222317.
AltiVate® Anatomic Shoulder AG e+™ with Markers
K222592 · Encore Medical, L.P. · Jun 2023
AETOS Shoulder System
K230572 · Smith & Nephew, Inc. · Jun 2023
AETOS Shoulder System
K220847 · Smith & Nephew, Inc. · Jan 2023
AltiVate® Anatomic Shoulder AG e+™ with Markers
K213387 · Encore Medical, L.P. · Jul 2022
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
K213785 · Limacorporate · May 2022
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)
K213827 · Smith & Nephew, Inc. · Mar 2022