Cleared Special

M2A 28MM RINGLOC LINER (K002379) - FDA 510(k) Clearance

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

K002379 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
27d
Days
Class 3
Risk

K002379 is an FDA 510(k) clearance for the M2A 28MM RINGLOC LINER. 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 August 31, 2000 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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 K002379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2000
Decision Date August 31, 2000
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K002379.
M2A ACETABULAR SYSTEM
K011110 · Biomet, Inc. · Jul 2001
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K003523 · DePuy Orthopaedics, Inc. · Dec 2000
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K002883 · DePuy Orthopaedics, Inc. · Oct 2000
ULTIMA METAL-ON-METAL ACETABULAR CUP
K001523 · DePuy Orthopaedics, Inc. · Aug 2000
METAL ON METAL ACETABULAR SYSTEM
K993438 · Biomet, Inc. · May 2000
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768 · Osteonics Corp. · Jan 1988