Cleared Traditional

K962224 - SELECT SHOULDER CONCENTRIC HUMERAL HEAD...

K962224 is an FDA 510(k) clearance for SELECT SHOULDER CONCENTRIC HUMERAL HEAD..., manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K962224 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
79d
Days
Class 2
Risk

K962224 is an FDA 510(k) clearance for the SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on August 28, 1996 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K962224

510(k) Number K962224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1996
Decision Date August 28, 1996
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. 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 153
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K962224.
DEPUY GLOBAL SHOULDER GLENOID
K981487 · DePuy Orthopaedics, Inc. · Jul 1998
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
K974044 · DePuy Orthopaedics, Inc. · Jan 1998
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
K971715 · Sulzer Orthopedics, Inc. · Aug 1997
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
K962082 · Osteonics Corp. · Aug 1996
FOUNDATION GLENOID COMPONENT
K960906 · Encore Orthopedics, Inc. · Apr 1996
OSTEONICS N2/VAC PACKAGING PROCESS
K955944 · Osteonics Corp. · Apr 1996