Cleared Traditional

K960643 - ADVANTAGE MAPF HIP FEMORAL COMPONENT

K960643 is the FDA 510(k) clearance for ADVANTAGE MAPF HIP FEMORAL COMPONENT by Biomet, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 76
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K960643.
ODC B2 BIPOLAR CUP
K982389 · Ortho Development Corp. · Oct 1998
J-FX BIPOLAR HEAD
K980801 · Johnson & Johnson Professionals, Inc. · May 1998
IMPLEX BIPOLAR HIP SYSTEM
K970447 · Implex Corp. · 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