Cleared Traditional

LEINBACH HIP PROSTHESIS (K896257) - FDA 510(k) Clearance

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

K896257 · 3M Company · Orthopedic device
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Jan 1990
Decision
81d
Days
Class 2
Risk

K896257 is an FDA 510(k) clearance for the LEINBACH HIP PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 81 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 3M Company devices

Submission Details

510(k) Number K896257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date January 19, 1990
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 K896257.
P.F.C. TOTAL HIP SYSTEM
K944132 · Johnson & Johnson Professionals, Inc. · Jan 1995
IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM
K925153 · Howmedica Corp. · Mar 1994
EXACTECH BIPOLAR HIP PROSTHESIS
K905370 · Exactech, Inc. · Feb 1991
BATEMAN UPF II HIP PROSTHESIS SYSTEM
K895120 · 3M Company · Jan 1990
VS22 HIP PROSTHESIS
K896266 · 3M Company · Nov 1989
P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT
K893872 · Johnson & Johnson Professionals, Inc. · Sep 1989