Cleared Traditional

K063550 - SYSTEM 12 CONSTRAINED ACETABULAR LINERS

K063550 is the FDA 510(k) clearance for SYSTEM 12 CONSTRAINED ACETABULAR LINERS by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code KWZ) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K063550 · Howmedica Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2007
Decision
104d
Days
Class 2
Risk

K063550 is an FDA 510(k) clearance for the SYSTEM 12 CONSTRAINED ACETABULAR LINERS. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (product code KWZ), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on March 8, 2007 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3310 - 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. Standard predicate reliance. 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K063550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2006
Decision Date March 08, 2007
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3310
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 - KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

All 31
Devices cleared under the same product code (KWZ) and FDA review panel - the closest regulatory comparables to K063550.
TRILOGY LONGEVITY CONSTRAINED LINER
K071718 · Zimmer, Inc. · Jul 2007
MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS
K071117 · DePuy Orthopaedics, Inc. · May 2007
PCA CONSTRAINED ACETABULAR LINERS
K063445 · Howmedica Osteonics Corp. · Mar 2007
SERIES II CONSTRAINED ACETABULAR LINERS
K063552 · Howmedica Osteonics Corp. · Mar 2007
TRIDENT CONSTRAINED ACETABULAR INSERT
K061654 · Howmedica Osteonics Corp. · Jul 2006
PINNACLE CONSTRAINED ACETABULAR LINERS
K052079 · DePuy Orthopaedics, Inc. · Oct 2005