Cleared Traditional

K172551 - Trinity PLUS Acetabular Shell

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

K172551 · Corin U.S.A. Limited · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K172551

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.

LPH Device Classification - Class 2, Special Controls

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 534
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