Cleared Traditional

K960643 - ADVANTAGE MAPF HIP FEMORAL COMPONENT

K960643 is an FDA 510(k) clearance for ADVANTAGE MAPF HIP FEMORAL COMPONENT, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K960643 · Biomet, Inc. · Orthopedic device
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Dec 1996
Decision
306d
Days
Class 2
Risk

K960643 is an FDA 510(k) clearance for the ADVANTAGE MAPF HIP FEMORAL COMPONENT. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K960643

510(k) Number K960643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1996
Decision Date December 16, 1996
Days to Decision 306 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 122d · This submission: 306d
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 93
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K960643.
J-FX BIPOLAR HEAD
K980801 · Johnson & Johnson Professionals, Inc. · May 1998
IMPLEX BIPOLAR HIP SYSTEM
K970447 · Implex Corp. · Apr 1997
ARTOS, DIPLOS SYSTEM
K970284 · Turnkey Intergration USA, Inc. · Apr 1997
ULTIMA FX FEMORAL HIP STEMS
K963885 · Johnson & Johnson Professionals, Inc. · Dec 1996
PRIMALOC CEMENTED HIP SYSTEM
K962448 · Ortho Development Corp. · Sep 1996
BI-LOC BIPOLAR CUP
K961793 · Ortho Development Corp. · Jul 1996