Cleared Special

CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL (K041425) - FDA 510(k) Clearance

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

K041425 · Wrightmedicaltechnologyinc · Orthopedic device
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Jun 2004
Decision
28d
Days
Class 3
Risk

K041425 is an FDA 510(k) clearance for the CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on June 25, 2004 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K041425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2004
Decision Date June 25, 2004
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.

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 K041425.
PROCOTYL-E ACETABULAR SYSTEM
K043073 · Wrightmedicaltechnologyinc · May 2005
CONSERVE PLUS HA ACETABULAR SHELLS
K042530 · Wrightmedicaltechnologyinc · Dec 2004
M2A MAGNUM SYSTEM
K042037 · Biomet, Inc. · Oct 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
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
K021349 · Wrightmedicaltechnologyinc · Jul 2002