Cleared Traditional

K940537 - KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM (FDA 510(k) Clearance)

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

K940537 · Kirschner Medical Corp. · Orthopedic device
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Aug 1995
Decision
568d
Days
Class 2
Risk

K940537 is an FDA 510(k) clearance for the KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Fair Lawn, US). The FDA issued a Cleared decision on August 29, 1995 after a review of 568 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Kirschner Medical Corp. devices

Submission Details

510(k) Number K940537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1994
Decision Date August 29, 1995
Days to Decision 568 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
446d slower than avg
Panel avg: 122d · This submission: 568d
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 K940537.
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