Cleared Traditional

K904383 - ACUFIT TOTAL HIP

K904383 is an FDA 510(k) clearance for ACUFIT TOTAL HIP, manufactured by Acu Med, Inc.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K904383 · Acu Med, Inc. · Orthopedic device
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Dec 1990
Decision
85d
Days
Class 2
Risk

K904383 is an FDA 510(k) clearance for the ACUFIT TOTAL HIP. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on December 20, 1990 after a review of 85 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 Acu Med, Inc. devices

FDA 510(k) Submission Details - K904383

510(k) Number K904383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1990
Decision Date December 20, 1990
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 91
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K904383.
CONSENSUS(TM) BIPOLAR SYSTEM
K922560 · U.S. Medical Products, Inc. · Sep 1992
BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM
K913632 · Kirschner Medical Corp. · Nov 1991
EXACTECH BIPOLAR HIP PROSTHESIS
K905370 · Exactech, Inc. · Feb 1991
LEINBACH HIP PROSTHESIS
K896257 · 3M Company · Jan 1990
BATEMAN UPF II HIP PROSTHESIS SYSTEM
K895120 · 3M Company · Jan 1990
VS22 HIP PROSTHESIS
K896266 · 3M Company · Nov 1989