Cleared Traditional

K925883 - OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS

K925883 is an FDA 510(k) clearance for OSTEONICS MICROSTRUCTURED ACETABULAR CO..., manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JDJ cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K925883 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
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Jun 1993
Decision
208d
Days
Class 2
Risk

K925883 is an FDA 510(k) clearance for the OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS. Classified as Mesh, Surgical, Acetabular, Hip, Prosthesis (product code JDJ), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on June 15, 1993 after a review of 208 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

FDA 510(k) Submission Details - K925883

510(k) Number K925883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1992
Decision Date June 15, 1993
Days to Decision 208 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
86d slower than avg
Panel avg: 122d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDJ Device Classification - Class 2, Special Controls

Product Code JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis
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.