Cleared Traditional

M2A MAGNUM SYSTEM (K042037) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K042037 · Biomet, Inc. · Orthopedic device
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Oct 2004
Decision
64d
Days
Class 3
Risk

K042037 is an FDA 510(k) clearance for the M2A MAGNUM SYSTEM. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 1, 2004 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - 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: High-complexity regulatory submission. High regulatory complexity 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 K042037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2004
Decision Date October 01, 2004
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3330
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

All 57
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K042037.
BALANCE HIP SYSTEM
K050251 · Biomet, Inc. · May 2005
PROCOTYL-E ACETABULAR SYSTEM
K043073 · Wrightmedicaltechnologyinc · May 2005
CONSERVE PLUS HA ACETABULAR SHELLS
K042530 · Wrightmedicaltechnologyinc · Dec 2004
CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL
K041425 · Wrightmedicaltechnologyinc · Jun 2004
CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD
K031963 · Wrightmedicaltechnologyinc · Oct 2003
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
K023786 · DePuy Orthopaedics, Inc. · Dec 2002