Cleared Traditional

OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT (K962082) - FDA 510(k) Clearance

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

K962082 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
76d
Days
Class 2
Risk

K962082 is an FDA 510(k) clearance for the OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 13, 1996 after a review of 76 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 Osteonics Corp. devices

Submission Details

510(k) Number K962082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1996
Decision Date August 13, 1996
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 91
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K962082.
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
K990598 · Howmedica Osteonics Corp. · Mar 1999
DEPUY GLOBAL SHOULDER GLENOID
K981487 · DePuy Orthopaedics, Inc. · Jul 1998
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
K974044 · DePuy Orthopaedics, Inc. · Jan 1998
OSTEONICS N2/VAC PACKAGING PROCESS
K955944 · Osteonics Corp. · Apr 1996
OSTEONICS SHOULDER HUMERAL COMPONENTS
K955731 · Osteonics Corp. · Mar 1996
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
K950521 · Osteonics Corp. · Jun 1995