Cleared Traditional

K870234 - P.T.H. METAL-BACKED ACETABULAR CUP (FDA 510(k) Clearance)

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

K870234 · Orthopaedic Device Corp. · Orthopedic device
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Mar 1987
Decision
58d
Days
Class 3
Risk

K870234 is an FDA 510(k) clearance for the P.T.H. METAL-BACKED ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Orthopaedic Device Corp. (Allendale, US). The FDA issued a Cleared decision on March 20, 1987 after a review of 58 days - a notably fast clearance cycle.

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.

View all Orthopaedic Device Corp. devices

Submission Details

510(k) Number K870234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1987
Decision Date March 20, 1987
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 122d · This submission: 58d
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.