Cleared Traditional

K942891 - SUMMIT TOTAL HIP SYSTEM

K942891 is an FDA 510(k) clearance for SUMMIT TOTAL HIP SYSTEM, manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K942891 · Kirschner Medical Corp. · Orthopedic device
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Nov 1994
Decision
135d
Days
Class 2
Risk

K942891 is an FDA 510(k) clearance for the SUMMIT TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Fair Lawn, US). The FDA issued a Cleared decision on November 2, 1994 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K942891

510(k) Number K942891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1994
Decision Date November 02, 1994
Days to Decision 135 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 122d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 132
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K942891.
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