Cleared Special

K002883 - PINNACLE METAL-ON-METAL ACETABULAR CUP ...

K002883 is an FDA 510(k) clearance for PINNACLE METAL-ON-METAL ACETABULAR CUP ..., manufactured by DePuy Orthopaedics, Inc.. The device is a Class 3 Orthopedic device with product code KWA cleared through the Special 510(k) pathway after a 28-day FDA review.

K002883 · DePuy Orthopaedics, Inc. · Orthopedic device
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Oct 2000
Decision
28d
Days
Class 3
Risk

K002883 is an FDA 510(k) clearance for the PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 13, 2000 after a review of 28 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K002883

510(k) Number K002883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2000
Decision Date October 13, 2000
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KWA Device Classification - Class 3, Premarket Approval

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 98
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K002883.
ALLOFIT ACETABULAR SYSTEM
K003758 · Sulzer Orthopedics, Inc. · Mar 2001
FMP METAL/METAL ACETABULAR INSERT
K003250 · Encore Orthopedics, Inc. · Jan 2001
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K003523 · DePuy Orthopaedics, Inc. · Dec 2000
M2A 28MM RINGLOC LINER
K002379 · Biomet, Inc. · Aug 2000
ULTIMA METAL-ON-METAL ACETABULAR CUP
K001523 · DePuy Orthopaedics, Inc. · Aug 2000
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
K001536 · Sulzer Orthopedics, Inc. · Jul 2000