Cleared Traditional

K970567 - SELECT SHOULDER CURVED-BACK PEGGED ALL ...

K970567 is an FDA 510(k) clearance for SELECT SHOULDER CURVED-BACK PEGGED ALL ..., 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 14-day FDA review.

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

FDA 510(k) Submission Details - K970567

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
Combination Product No
PCCP Authorized No
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.

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 K970567.
GRIT BLASTED HUMERAL STEM
K991603 · Encore Orthopedics, Inc. · Jun 1999
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
K984541 · DePuy Orthopaedics, Inc. · Jan 1999
NEW ZIMMER SHOULDER SYSTEM
K982981 · Zimmer, Inc. · Dec 1998
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
K962315 · Intermedics Orthopedics · Sep 1996
SELECT SHOULDER KEELED ALL-POLY GLENOIDS
K962238 · Intermedics Orthopedics · Aug 1996
SELECT SHOULDER PEGGED ALL-POLY GLENOID
K962244 · Intermedics Orthopedics · Aug 1996