Cleared Traditional

K941534 - MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM

K941534 is the FDA 510(k) clearance for MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM by 3M Health Care, Ltd.. It is a Class 2 Orthopedic device (product code KWY) cleared through the Traditional 510(k) pathway after a 341-day FDA review.

K941534 · 3M Health Care, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
341d
Days
Class 2
Risk

K941534 is an FDA 510(k) clearance for the MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on March 6, 1995 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 3M Health Care, Ltd. devices

Submission Details

510(k) Number K941534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1994
Decision Date March 06, 1995
Days to Decision 341 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
219d slower than avg
Panel avg: 122d · This submission: 341d
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 76
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K941534.
UHMWPE COMPONENTS-CHANGE IN PACKAGING
K940743 · Depuy, Inc. · Sep 1995
HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS
K953510 · Encore Orthopedics, Inc. · Aug 1995
P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR
K945793 · Johnson & Johnson Professionals, Inc. · Apr 1995
P.F.C. TOTAL HIP SYSTEM
K944132 · Johnson & Johnson Professionals, Inc. · Jan 1995
IOI COCR UNIPOLAR PROSTHESIS
K934159 · Intermedics Orthopedics · Jul 1994
IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM
K925153 · Howmedica Corp. · Mar 1994