Cleared Traditional

K153725 - Corin TaperFit Hip Stem

K153725 is an FDA 510(k) clearance for Corin TaperFit Hip Stem, manufactured by Corin U.S.A. Limited. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K153725 · Corin U.S.A. Limited · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
88d
Days
Class 2
Risk

K153725 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 U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on March 25, 2016 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K153725

510(k) Number K153725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2015
Decision Date March 25, 2016
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 528
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K153725.
MALUC™ Total Hip Arthroplasty System
K162125 · Surgtech, Inc. · May 2017
REDAPT Anteverted Cemented Liner
K160923 · Smith & Nephew, Inc. · Nov 2016
FitRite™ Total Hip Arthroplasty System
K153057 · Excera Orthopedics, Inc. · Jun 2016
Alpine Cemented Hip System
K153216 · Ortho Development Corporation · Feb 2016
OSS/Arcos IM Total Femur Rod
K152621 · Biomet, Inc. · Oct 2015
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
K142814 · Biomet Manufacturing, LLC · Jun 2015