Cleared Traditional

K872528 - OMNIFIT DISTAL STEM CEMENT SPACERS (FDA 510(k) Clearance)

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

K872528 · Osteonics Corp. · Orthopedic device
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Dec 1987
Decision
187d
Days
Class 2
Risk

K872528 is an FDA 510(k) clearance for the OMNIFIT DISTAL STEM CEMENT SPACERS. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 187 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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 Osteonics Corp. devices

Submission Details

510(k) Number K872528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1987
Decision Date December 29, 1987
Days to Decision 187 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 122d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDK Prosthesis, Hip, Cement Restrictor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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.