Cleared Traditional

K242744 - Trinity EVO Acetabular Shell

K242744 is an FDA 510(k) clearance for Trinity EVO 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 267-day FDA review.

K242744 · Corin U.S.A. Limited · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
267d
Days
Class 2
Risk

K242744 is an FDA 510(k) clearance for the Trinity EVO 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 5, 2025 after a review of 267 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 - K242744

510(k) Number K242744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2024
Decision Date June 05, 2025
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
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 K242744.
ArTT Augments and Buttresses and Bone Screws
K251718 · Lima Corporate S.P.A. · Aug 2025
Stryker and Serf hip devices
K250989 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jul 2025
ONVOY™ Acetabular System
K243456 · Globus Medical, Inc. · Jun 2025
Mpact 3D Metal Augments II
K242232 · Medacta International S.A. · Apr 2025
Initia T3 Acetabular Hemispherical Shell System
K242045 · Kyocera Medical Technologies, Inc. · Apr 2025
Stryker Orthopaedics Hip Devices Labeling Update
K243784 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Feb 2025