Cleared Traditional

K903877 - MTS FEMORAL HIP SYSTEM

K903877 is an FDA 510(k) clearance for MTS FEMORAL HIP SYSTEM, manufactured by 3M Company. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K903877 · 3M Company · Orthopedic device
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Jan 1991
Decision
149d
Days
Class 2
Risk

K903877 is an FDA 510(k) clearance for the MTS FEMORAL HIP SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 149 days - within the typical 510(k) review window.

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 3M Company devices

FDA 510(k) Submission Details - K903877

510(k) Number K903877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1990
Decision Date January 18, 1991
Days to Decision 149 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 122d · This submission: 149d
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 81
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K903877.
OMNIFLEX M-HA HIP STEM SERIES
K920193 · Stryker Corp. · Jun 1992
OMNIFIT M-HA HIP STEM SERIES
K920231 · Stryker Corp. · Jun 1992
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
K915868 · Orthomet, Inc. · Mar 1992
MODULAR UNIPOLAR SYSTEM
K902365 · Howmedica Corp. · Jan 1991
PROFILE COLLARED HIP PROSTHESIS
K904119 · Depuy, Inc. · Oct 1990
KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD
K903884 · Kinamed, Inc. · Sep 1990