Cleared Traditional

K153131 - Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner

K153131 is an FDA 510(k) clearance for Logical C-Series Acetabular Shell, manufactured by Signature Orthopaedics Pty, Ltd.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K153131 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
217d
Days
Class 2
Risk

K153131 is an FDA 510(k) clearance for the Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constra.... Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on June 3, 2016 after a review of 217 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Signature Orthopaedics Pty, Ltd. devices

FDA 510(k) Submission Details - K153131

510(k) Number K153131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2015
Decision Date June 03, 2016
Days to Decision 217 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
95d slower than avg
Panel avg: 122d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 152
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K153131.
H-Max S stem
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K160907 · Depuy(Ireland) · Jul 2016
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K161155 · Signature Orthopaedics Pty, Ltd. · Jul 2016
Corin TriFit TS Hip
K153772 · Corin U.S.A. Limited · Mar 2016
H-MAX S Femoral Hip System
K150855 · Lima Corporate S.P.A. · Oct 2015
DePuy Actis Duofox Hip Prosthesis
K150862 · DePuy Orthopaedics, Inc. · Sep 2015