Cleared Traditional

OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP (K963671) - FDA 510(k) Clearance

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

K963671 · Osteonics Corp. · Orthopedic device
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Feb 1997
Decision
143d
Days
Class 2
Risk

K963671 is an FDA 510(k) clearance for the OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on February 3, 1997 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 K963671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1996
Decision Date February 03, 1997
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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.

Regulatory Peers - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K963671.
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K970697 · Osteonics Corp. · Apr 1997
CEMENTED CALCAR REPLACEMENT FEMORAL STEM
K964795 · Johnson & Johnson Professionals, Inc. · Feb 1997
UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
K964655 · Howmedica Corp. · Feb 1997
HERITAGE HIP SYSTEM
K963109 · Zimmer, Inc. · Jan 1997
PERFECTA PLASMA SPRAY HIP STEM
K964218 · Wrightmedicaltechnologyinc · Jan 1997
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
K964262 · Exactech, Inc. · Dec 1996