Cleared Traditional

SELECT(R) SHOULDER ALL POLY GLENOID (K935802) - FDA 510(k) Clearance

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

K935802 · Intermedics Orthopedics · Orthopedic device
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May 1995
Decision
536d
Days
Class 2
Risk

K935802 is an FDA 510(k) clearance for the SELECT(R) SHOULDER ALL POLY GLENOID. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on May 22, 1995 after a review of 536 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Intermedics Orthopedics devices

Submission Details

510(k) Number K935802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date May 22, 1995
Days to Decision 536 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
414d slower than avg
Panel avg: 122d · This submission: 536d
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 92
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K935802.
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
DEPUY POROUS COATED GLOBAL SHOULDER
K943300 · Depuy, Inc. · Oct 1994
NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT
K902855 · Depuy, Inc. · Sep 1990
NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS
K895226 · 3M Company · Nov 1989