Cleared Traditional

ULTIMA FX FEMORAL HIP STEMS (K963885) - FDA 510(k) Clearance

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

K963885 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Dec 1996
Decision
74d
Days
Class 2
Risk

K963885 is an FDA 510(k) clearance for the ULTIMA FX FEMORAL HIP STEMS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on December 9, 1996 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 K963885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1996
Decision Date December 09, 1996
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 47
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K963885.
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
K982812 · Johnson & Johnson Professionals, Inc. · Dec 1998
J-FX BIPOLAR HEAD
K980801 · Johnson & Johnson Professionals, Inc. · May 1998
ADVANTAGE MAPF HIP FEMORAL COMPONENT
K960643 · Biomet, Inc. · Dec 1996
P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
K945518 · Johnson & Johnson Professionals, Inc. · Mar 1996
UHMWPE COMPONENTS-CHANGE IN PACKAGING
K940743 · Depuy, Inc. · Sep 1995
P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR
K945793 · Johnson & Johnson Professionals, Inc. · Apr 1995