Cleared Traditional

K885146 - CL UNIVERSAL HIP DEVICE

K885146 is an FDA 510(k) clearance for CL UNIVERSAL HIP DEVICE, manufactured by Lima Intl. Corp.. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K885146 · Lima Intl. Corp. · Orthopedic device
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Apr 1989
Decision
130d
Days
Class 2
Risk

K885146 is an FDA 510(k) clearance for the CL UNIVERSAL HIP DEVICE. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Lima Intl. Corp. (E Providence, US). The FDA issued a Cleared decision on April 24, 1989 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3170 - 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 Lima Intl. Corp. devices

FDA 510(k) Submission Details - K885146

510(k) Number K885146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1988
Decision Date April 24, 1989
Days to Decision 130 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWI Device Classification - Class 2, Special Controls

Product Code KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3170
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.