Cleared Traditional

K894965 - POROUS-COATED TITANIUM ACETABULAR CUP (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K894965 · Dow Corning Wright · Orthopedic device
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Nov 1989
Decision
102d
Days
Class 3
Risk

K894965 is an FDA 510(k) clearance for the POROUS-COATED TITANIUM ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3320 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K894965 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 07, 1989
Decision Date November 17, 1989
Days to Decision 102 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3320
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.