Cleared Traditional

K142761 - Corin TaperFit Hip Stem

K142761 is an FDA 510(k) clearance for Corin TaperFit Hip Stem, manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K142761 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
190d
Days
Class 2
Risk

K142761 is an FDA 510(k) clearance for the Corin TaperFit Hip Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on April 3, 2015 after a review of 190 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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

FDA 510(k) Submission Details - K142761

510(k) Number K142761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2014
Decision Date April 03, 2015
Days to Decision 190 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
68d slower than avg
Panel avg: 122d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 466
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K142761.
Libertas Hip Replacement System
K180973 · Maxx Orthopedics, Inc. · Sep 2018
REDAPT Anteverted Cemented Liner
K160923 · Smith & Nephew, Inc. · Nov 2016
OSS/Arcos IM Total Femur Rod
K152621 · Biomet, Inc. · Oct 2015
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
K141331 · Biomet, Inc. · Oct 2014
Sirius Femoral Stem, Size 30A
K142295 · Biomet, Inc. · Sep 2014
SIRIUS FEMORAL STEM
K130610 · Biomet, Inc. · Aug 2013