Cleared Traditional

SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS (K970567) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970567 · Intermedics Orthopedics · Orthopedic device
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Feb 1997
Decision
14d
Days
Class 2
Risk

K970567 is an FDA 510(k) clearance for the SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS. 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 February 27, 1997 after a review of 14 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

Submission Details

510(k) Number K970567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1997
Decision Date February 27, 1997
Days to Decision 14 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 122d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 43
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K970567.
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K982981 · Zimmer, Inc. · Dec 1998
COCR BI-ANGULAR HUMERAL COMPONENT
K961571 · Biomet, Inc. · Aug 1996
PROXIMAL HUMERAL REPLACEMENT SYSTEM
K925613 · Biomet, Inc. · Oct 1994
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
K915596 · Biomet, Inc. · Mar 1992