Cleared Traditional

CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS (K110087) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110087 · Corin USA · Orthopedic device
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May 2011
Decision
111d
Days
Class 2
Risk

K110087 is an FDA 510(k) clearance for the CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on May 3, 2011 after a review of 111 days - within the typical 510(k) review window.

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 Corin USA devices

Submission Details

510(k) Number K110087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2011
Decision Date May 03, 2011
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 309
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K110087.
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K120211 · Smith & Nephew, Inc. · Jul 2012
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K110101 · Smith & Nephew, Inc. · Apr 2011
DEPUY CORAIL HIP SYSTEM, REVISION STEM
K093736 · DePuy Orthopaedics, Inc. · Mar 2011
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K103233 · Howmedica Osteonics Corp. · Feb 2011