Cleared Special

K010243 - TRI-FIT FEMORAL STEM

K010243 is an FDA 510(k) clearance for TRI-FIT FEMORAL STEM, manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Special 510(k) pathway after a 21-day FDA review.

K010243 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
21d
Days
Class 2
Risk

K010243 is an FDA 510(k) clearance for the TRI-FIT FEMORAL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on February 15, 2001 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Corin USA devices

FDA 510(k) Submission Details - K010243

510(k) Number K010243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2001
Decision Date February 15, 2001
Days to Decision 21 days
Submission Type Special
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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 62
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K010243.
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122 · DePuy Orthopaedics, Inc. · Feb 2003
UNI HIP STEM
K024134 · Plus Orthopedics · Jan 2003
PROXILOCK HIP PROSTHESIS
K022966 · Implex Corp. · Oct 2002
PRO-FEMUR R
K003016 · Wrightmedicaltechnologyinc · Dec 2000
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
K994146 · Plus Orthopedics · Dec 2000
ACETABULAR PLATES
K002941 · Encore Orthopedics, Inc. · Dec 2000