Cleared Traditional

K965198 - ULTIMA TPS CEMENTED STEM

K965198 is an FDA 510(k) clearance for ULTIMA TPS CEMENTED STEM, manufactured by Johnson & Johnson International. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 209-day FDA review.

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

FDA 510(k) Submission Details - K965198

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
Combination Product No
PCCP Authorized No
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.

KWL Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K965198.
ARGOMEDICAL BIPOLAR SYSTEM
K981451 · Stelkast Company · Aug 1998
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
K974807 · Osteonics Corp. · Mar 1998
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
K973614 · Encore Orthopedics, Inc. · Dec 1997
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
K965156 · Johnson & Johnson Professionals, Inc. · Jan 1997
PRIME MODULAR ENDO HEAD
K962646 · Orthopaedic Innovations, Inc. · Sep 1996
OPTEON UNIPOLAR
K960538 · Exactech, Inc. · Mar 1996