Cleared Traditional

K895802 - NON CONSTRAINED TOTAL SHOULDER SYSTEM (FDA 510(k) Clearance)

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

K895802 · Orthopaedic Medical Group, Inc. · Orthopedic device
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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.

View all Orthopaedic Medical Group, Inc. devices

Submission Details

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
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.

Device Classification

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 70
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K895802.
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InSet Total Shoulder System
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