Cleared Traditional

K962244 - SELECT SHOULDER PEGGED ALL-POLY GLENOID

K962244 is an FDA 510(k) clearance for SELECT SHOULDER PEGGED ALL-POLY GLENOID, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K962244 · Intermedics Orthopedics · Orthopedic device
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Aug 1996
Decision
59d
Days
Class 2
Risk

K962244 is an FDA 510(k) clearance for the SELECT SHOULDER PEGGED ALL-POLY GLENOID. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on August 9, 1996 after a review of 59 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K962244

510(k) Number K962244 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 11, 1996
Decision Date August 09, 1996
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 122d · This submission: 59d
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 59
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K962244.
SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
K970567 · Intermedics Orthopedics · Feb 1997
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
K962315 · Intermedics Orthopedics · Sep 1996
SELECT SHOULDER KEELED ALL-POLY GLENOIDS
K962238 · Intermedics Orthopedics · Aug 1996
COCR BI-ANGULAR HUMERAL COMPONENT
K961571 · Biomet, Inc. · Aug 1996
KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
K940537 · Kirschner Medical Corp. · Aug 1995
PROXIMAL HUMERAL REPLACEMENT SYSTEM
K925613 · Biomet, Inc. · Oct 1994