Cleared Traditional

K965156 - ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES

K965156 is the FDA 510(k) clearance for ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES by Johnson & Johnson Professionals, Inc.. It is a Class 2 Orthopedic device (product code KWL) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K965156 · Johnson & Johnson Professionals, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
32d
Days
Class 2
Risk

K965156 is an FDA 510(k) clearance for the ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 32 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K965156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date January 24, 1997
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
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 77
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K965156.
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
OPTEON UNIPOLAR
K960538 · Exactech, Inc. · Mar 1996
JOHNSON & JOHNSON AUSTIN MOORE STEM
K955385 · Johnson & Johnson Professionals, Inc. · Jan 1996
OSTEONICS UNIPOLAR ENDO HEAD
K954534 · Osteonics Corp. · Nov 1995