Cleared Traditional

K895120 - BATEMAN UPF II HIP PROSTHESIS SYSTEM

K895120 is an FDA 510(k) clearance for BATEMAN UPF II HIP PROSTHESIS SYSTEM, manufactured by 3M Company. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K895120 · 3M Company · Orthopedic device
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Jan 1990
Decision
149d
Days
Class 2
Risk

K895120 is an FDA 510(k) clearance for the BATEMAN UPF II HIP PROSTHESIS SYSTEM. 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 11, 1990 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 888.3390 - 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. 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 - K895120

510(k) Number K895120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1989
Decision Date January 11, 1990
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.

KWY Device Classification - Class 2, Special Controls

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 K895120.
EXACTECH BIPOLAR HIP PROSTHESIS
K905370 · Exactech, Inc. · Feb 1991
ACUFIT TOTAL HIP
K904383 · Acu Med, Inc. · Dec 1990
LEINBACH HIP PROSTHESIS
K896257 · 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
ZIMMER BEADED THREADED ACETABULAR CUP
K884658 · Zimmer, Inc. · Nov 1988