Cleared Traditional

K895802 - NON CONSTRAINED TOTAL SHOULDER SYSTEM

K895802 is an FDA 510(k) clearance for NON CONSTRAINED TOTAL SHOULDER SYSTEM, manufactured by Orthopaedic Medical Group, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K895802 · Orthopaedic Medical Group, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
90d
Days
Class 2
Risk

K895802 is an FDA 510(k) clearance for the NON CONSTRAINED TOTAL SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Orthopaedic Medical Group, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 27, 1989 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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.

FDA 510(k) Submission Details - K895802

510(k) Number K895802 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 28, 1989
Decision Date December 27, 1989
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWT Device Classification - Class 2, Special Controls

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 71
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K895802.
GLOBAL TOTAL SHOULDER
K914695 · Depuy, Inc. · Jan 1992
GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE
K914000 · Depuy, Inc. · Dec 1991
GLOBAL TOTAL SHOULDER
K905786 · Depuy, Inc. · Mar 1991
NEER-III GLENOID RESURFACING PROSTHESIS
K873104 · Kirschner Medical Corp. · Oct 1987
NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.
K873620 · Kirschner Medical Corp. · Oct 1987
NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS
K873621 · Kirschner Medical Corp. · Oct 1987
K895802 · NON CONSTRAINED TOTAL SHOULDER SYSTEM
Download PDF Orthopaedic Medical G…