Cleared Traditional

K950521 - OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT

K950521 is an FDA 510(k) clearance for OSTEONICS ALL POLYETHYLENE GLENOID SHOU..., manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K950521 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
130d
Days
Class 2
Risk

K950521 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 June 16, 1995 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteonics Corp. devices

FDA 510(k) Submission Details - K950521

510(k) Number K950521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1995
Decision Date June 16, 1995
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
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 185
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K950521.
COFIED MODULAR SHOULDER SYSTEM
K955767 · Smith & Nephew Richards, Inc. · Apr 1996
OSTEONICS SHOULDER HUMERAL COMPONENTS
K955731 · Osteonics Corp. · Mar 1996
AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS
K952928 · Tornier · Sep 1995
TOTAL SHOULDER PROSTHESIS
K950651 · Encore Orthopedics, Inc. · May 1995
SELECT(R) SHOULDER ALL POLY GLENOID
K935802 · Intermedics Orthopedics · May 1995
DEPUY POROUS COATED GLOBAL SHOULDER
K943300 · Depuy, Inc. · Oct 1994