Cleared Traditional

MTS FEMORAL HIP SYSTEM (K903877) - FDA 510(k) Clearance

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

K903877 · 3M Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 49
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K903877.
ULTIMA AUGMENTED UHMWPE CUP
K950563 · Johnson & Johnson Professionals, Inc. · Jun 1995
CONTOUR FEMORAL HIP STEM WITH POROCOAT
K926120 · Depuy, Inc. · Mar 1993
OSTRONCS HEMI-HIP STEM SERIES
K922146 · Osteonics Corp. · Aug 1992
MODULAR UNIPOLAR SYSTEM
K902365 · Howmedica Corp. · Jan 1991
PROFILE COLLARED HIP PROSTHESIS
K904119 · Depuy, Inc. · Oct 1990
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
K896853 · Howmedica Corp. · May 1990