Cleared Traditional

K920362 - 3M MODULAR SHOULDER SYSTEM

K920362 is an FDA 510(k) clearance for 3M MODULAR SHOULDER SYSTEM, manufactured by 3M Health Care, Ltd.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 541-day FDA review.

K920362 · 3M Health Care, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
541d
Days
Class 2
Risk

K920362 is an FDA 510(k) clearance for the 3M MODULAR SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 541 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 3M Health Care, Ltd. devices

FDA 510(k) Submission Details - K920362

510(k) Number K920362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1992
Decision Date July 22, 1993
Days to Decision 541 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
419d slower than avg
Panel avg: 122d · This submission: 541d
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 158
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K920362.
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
NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT
K902855 · Depuy, Inc. · Sep 1990
PAPILLOTOME
K901434 · Telemed Systems, Inc. · Jun 1990
NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS
K895226 · 3M Company · Nov 1989