Cleared Traditional

K940190 - ULTIMA UNIPOLAR MODULAR HEAD

K940190 is an FDA 510(k) clearance for ULTIMA UNIPOLAR MODULAR HEAD, manufactured by Johnson & Johnson Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K940190 · Johnson & Johnson Orthopaedics, Inc. · Orthopedic device
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Sep 1994
Decision
259d
Days
Class 2
Risk

K940190 is an FDA 510(k) clearance for the ULTIMA UNIPOLAR MODULAR HEAD. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Johnson & Johnson Orthopaedics, Inc. (Raynham, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 259 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 Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K940190

510(k) Number K940190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1994
Decision Date September 29, 1994
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
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 88
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K940190.
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
K943778 · Osteonics Corp. · Aug 1995
ULTIMA AUGMENTED UHMWPE CUP
K950563 · Johnson & Johnson Professionals, Inc. · Jun 1995
LINK SADDLE PROTHESIS
K951355 · Turnkey Intergration USA, Inc. · May 1995
ZIRCONIUM ALLOY UNI-POLAR HEAD
K934353 · Smith & Nephew Richards, Inc. · Apr 1994
TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT
K924050 · Orthomet, Inc. · Aug 1993
CONTOUR FEMORAL HIP STEM WITH POROCOAT
K926120 · Depuy, Inc. · Mar 1993