Cleared Traditional

ULTIMA TPS CEMENTED STEM (K965198) - FDA 510(k) Clearance

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

K965198 · Johnson & Johnson International · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
209d
Days
Class 2
Risk

K965198 is an FDA 510(k) clearance for the ULTIMA TPS CEMENTED STEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Johnson & Johnson International (Raynham, US). The FDA issued a Cleared decision on July 23, 1997 after a review of 209 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Johnson & Johnson International devices

Submission Details

510(k) Number K965198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1996
Decision Date July 23, 1997
Days to Decision 209 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 122d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 50
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K965198.
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585 · Osteonics Corp. · Feb 1999
THE NEW BIO-MOORE ENDO HEADS
K984028 · Biomet, Inc. · Jan 1999
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
K974807 · Osteonics Corp. · Mar 1998
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
K965156 · Johnson & Johnson Professionals, Inc. · Jan 1997
OPTEON UNIPOLAR
K960538 · Exactech, Inc. · Mar 1996
JOHNSON & JOHNSON AUSTIN MOORE STEM
K955385 · Johnson & Johnson Professionals, Inc. · Jan 1996