Cleared Traditional

K981487 - DEPUY GLOBAL SHOULDER GLENOID

K981487 is an FDA 510(k) clearance for DEPUY GLOBAL SHOULDER GLENOID, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K981487 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
77d
Days
Class 2
Risk

K981487 is an FDA 510(k) clearance for the DEPUY GLOBAL SHOULDER GLENOID. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 13, 1998 after a review of 77 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K981487

510(k) Number K981487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1998
Decision Date July 13, 1998
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 183
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K981487.
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
K990598 · Howmedica Osteonics Corp. · Mar 1999
ANATOMICA GLENOID COMPONENT
K990136 · Sulzer Orthopedics, Inc. · Mar 1999
ANATOMICA HUMERAL STEM/HEAD COMPONENTS
K990137 · Sulzer Orthopedics, Inc. · Feb 1999
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
K974044 · DePuy Orthopaedics, Inc. · Jan 1998
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
K971715 · Sulzer Orthopedics, Inc. · Aug 1997
SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
K962224 · Intermedics Orthopedics · Aug 1996