Cleared Traditional

K896580 - UNI-POLAR HEAD

K896580 is an FDA 510(k) clearance for UNI-POLAR HEAD, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code LZY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K896580 · Richards Medical Co., Inc. · Orthopedic device
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Feb 1990
Decision
90d
Days
Class 2
Risk

K896580 is an FDA 510(k) clearance for the UNI-POLAR HEAD. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal Ball (product code LZY), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on February 15, 1990 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 888.3360 - 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K896580

510(k) Number K896580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1989
Decision Date February 15, 1990
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.

LZY Device Classification - Class 2, Special Controls

Product Code LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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.