Cleared Traditional

K172551 - Trinity PLUS Acetabular Shell

K172551 is the FDA 510(k) clearance for Trinity PLUS Acetabular Shell by Corin U.S.A. Limited. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K172551 · Corin U.S.A. Limited · Orthopedic device
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Jun 2018
Decision
296d
Days
Class 2
Risk

K172551 is an FDA 510(k) clearance for the Trinity PLUS Acetabular Shell. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Corin U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on June 15, 2018 after a review of 296 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 U.S.A. Limited devices

Submission Details

510(k) Number K172551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2017
Decision Date June 15, 2018
Days to Decision 296 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
174d slower than avg
Panel avg: 122d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 424
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K172551.
REDAPT Porous Acetabular Shell
K181366 · Smith & Nephew, Inc. · Sep 2018
Latitud Hip Replacement System
K172857 · Meril Healthcare Pvt. , Ltd. · Jul 2018
Prime Acetabular Cup System
K180798 · Microport Orthopedics, Inc. · Jul 2018
Legend Acetabular Liners
K173951 · Ortho Development Corporation · May 2018
Mpact® 3D Metal™ Implants and Augments 3D Metal™
K171966 · Medacta International S.A. · Mar 2018
Bone Screws 6.5mm
K172456 · Lima Corporate S.P.A. · Jan 2018